Trial Outcomes & Findings for Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) (NCT NCT02860130)

NCT ID: NCT02860130

Last Updated: 2025-07-22

Results Overview

The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 34 participants
• Primary outcome timeframe: Up to 120 hours post CRRT treatment initiation
• Results posted on: 2025-07-22

Participant Flow

Participant milestones

Measure	Prismocitrate 18 CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Overall Study STARTED	17	17
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	Prismocitrate 18 CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Overall Study Adverse Event	2	3
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	0	2
Overall Study Physician Decision	2	2
Overall Study Other	2	1

Baseline Characteristics

Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Baseline characteristics by cohort

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	Total n=34 Participants Total of all reporting groups
Age, Customized ≥ 18 years to ≤ 35 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized > 35 years to ≤ 45 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized > 45 years to ≤ 55 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized > 55 years to ≤ 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized > 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: Full Analysis Set (FAS)-randomized treatment groups (intent-to-treat principle)

The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions 25 Percentile	33.180 hours Interval 8.34 to Not reached due to early termination of study.	17.680 hours Interval 11.99 to 24.07
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions 50 Percentile	NA hours Not reached due to early termination of study.	29.660 hours Interval 23.73 to Not reached due to early termination of study.
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions 75 Percentile	NA hours Not reached due to early termination of study.	NA hours Interval 32.5 to Not reached due to early termination of study.

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Systemic blood iCa concentrations

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 1 Hour	-0.1 mmol/L Standard Deviation 0.14	0 mmol/L Standard Deviation 0.06
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 6 Hours	-0.1 mmol/L Standard Deviation 0.11	0 mmol/L Standard Deviation 0.07
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 12 Hours	-0.0 mmol/L Standard Deviation 0.17	0 mmol/L Standard Deviation 0.1
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 18 Hours	0 mmol/L Standard Deviation 0.18	0 mmol/L Standard Deviation 0.12
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 24 Hours	0.1 mmol/L Standard Deviation 0.19	-0.0 mmol/L Standard Deviation 0.17
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 30 Hours	0 mmol/L Standard Deviation 0.17	0 mmol/L Standard Deviation 0.13
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 36 Hours	0 mmol/L Standard Deviation 0.14	-0.0 mmol/L Standard Deviation 0.12
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 42 Hours	0 mmol/L Standard Deviation 0.18	0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 48 Hours	0 mmol/L Standard Deviation 0.15	0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 54 hours	0 mmol/L Standard Deviation 0.14	-0.0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 60 hours	0 mmol/L Standard Deviation 0.12	-0.0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 66 Hours	-0.0 mmol/L Standard Deviation 0.14	-0.0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 72 Hours	0 mmol/L Standard Deviation 0.13	0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 78 Hours	0 mmol/L Standard Deviation 0.16	0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 84 Hours	0 mmol/L Standard Deviation 0.15	-0.0 mmol/L Standard Deviation 0.17
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 90 Hours	0 mmol/L Standard Deviation 0.17	-0.0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 96 Hours	0 mmol/L Standard Deviation 0.11	-0.0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 102 Hours	0 mmol/L Standard Deviation 0.14	0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 108 Hours	0 mmol/L Standard Deviation 0.14	0 mmol/L Standard Deviation 0.16
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 114 Hours	0.1 mmol/L Standard Deviation 0.13	0 mmol/L Standard Deviation 0.15
Change From Baseline in Patient Ionized Calcium (iCa) by Hour 120 Hours	0.1 mmol/L Standard Deviation 0.14	-0.0 mmol/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Extracorporeal Circuit Ionized Calcium by Hour 114 Hours	0.4 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 1 Hour	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 6 Hours	0.5 mmol/L Standard Deviation 0.13	—
Extracorporeal Circuit Ionized Calcium by Hour 12 Hours	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 18 Hours	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 24 Hours	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 30 Hours	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 36 Hours	0.5 mmol/L Standard Deviation 0.1	—
Extracorporeal Circuit Ionized Calcium by Hour 42 Hours	0.5 mmol/L Standard Deviation 0.23	—
Extracorporeal Circuit Ionized Calcium by Hour 48 Hours	0.5 mmol/L Standard Deviation 0.12	—
Extracorporeal Circuit Ionized Calcium by Hour 54 hours	0.5 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 60 hours	0.5 mmol/L Standard Deviation 0.13	—
Extracorporeal Circuit Ionized Calcium by Hour 66 Hours	0.5 mmol/L Standard Deviation 0.17	—
Extracorporeal Circuit Ionized Calcium by Hour 72 Hours	0.4 mmol/L Standard Deviation 0.1	—
Extracorporeal Circuit Ionized Calcium by Hour 78 Hours	0.4 mmol/L Standard Deviation 0.12	—
Extracorporeal Circuit Ionized Calcium by Hour 84 Hours	0.4 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 90 Hours	0.4 mmol/L Standard Deviation 0.1	—
Extracorporeal Circuit Ionized Calcium by Hour 96 Hours	0.4 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 102 Hours	0.4 mmol/L Standard Deviation 0.13	—
Extracorporeal Circuit Ionized Calcium by Hour 108 Hours	0.4 mmol/L Standard Deviation 0.11	—
Extracorporeal Circuit Ionized Calcium by Hour 120 Hours	0.5 mmol/L Standard Deviation 0.16	—

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Delivery of Prescribed CRRT Dose by Day Day 1	32.3 mL/kg/hour Standard Deviation 7.064	30.34 mL/kg/hour Standard Deviation 7.407
Delivery of Prescribed CRRT Dose by Day Day 2	33.12 mL/kg/hour Standard Deviation 9.676	32.49 mL/kg/hour Standard Deviation 10.191
Delivery of Prescribed CRRT Dose by Day Day 3	31.62 mL/kg/hour Standard Deviation 8.045	32.29 mL/kg/hour Standard Deviation 10.533
Delivery of Prescribed CRRT Dose by Day Day 4	31.93 mL/kg/hour Standard Deviation 10.187	35.19 mL/kg/hour Standard Deviation 10.95
Delivery of Prescribed CRRT Dose by Day Day 5	32.83 mL/kg/hour Standard Deviation 11.119	33.31 mL/kg/hour Standard Deviation 13.103

SECONDARY outcome

Timeframe: Prior to study use of Prismocitrate 18

Population: Physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment at each Investigator site. Staff at each site facility passed testing, but the overall number of participants is not known. No analysis of investigator training test scores were conducted as results for individual test questions were not retained for analysis.

Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.

Outcome measures

Measure	Prismocitrate 18 n=6 site facilities CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment	6 site facility staff	—

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Bicarbonate by Hour 6 Hours	0.2 mmol/L Standard Deviation 3.86	2.4 mmol/L Standard Deviation 3.48
Change From Baseline in Serum Bicarbonate by Hour 12 Hours	0.8 mmol/L Standard Deviation 4.42	2.9 mmol/L Standard Deviation 3.27
Change From Baseline in Serum Bicarbonate by Hour 18 Hours	1.3 mmol/L Standard Deviation 5.43	2.3 mmol/L Standard Deviation 4.11
Change From Baseline in Serum Bicarbonate by Hour 24 Hours	2.8 mmol/L Standard Deviation 4.64	2 mmol/L Standard Deviation 4.99
Change From Baseline in Serum Bicarbonate by Hour 30 Hours	2.9 mmol/L Standard Deviation 5.02	2.9 mmol/L Standard Deviation 4.21
Change From Baseline in Serum Bicarbonate by Hour 36 Hours	3.3 mmol/L Standard Deviation 5.6	2.6 mmol/L Standard Deviation 3.71
Change From Baseline in Serum Bicarbonate by Hour 42 Hours	3.3 mmol/L Standard Deviation 5.52	3.6 mmol/L Standard Deviation 3.61
Change From Baseline in Serum Bicarbonate by Hour 48 Hours	2.7 mmol/L Standard Deviation 5.56	2.4 mmol/L Standard Deviation 3.99
Change From Baseline in Serum Bicarbonate by Hour 54 Hours	2.7 mmol/L Standard Deviation 5.72	2.1 mmol/L Standard Deviation 3.77
Change From Baseline in Serum Bicarbonate by Hour 60 Hours	4.7 mmol/L Standard Deviation 6.56	2.4 mmol/L Standard Deviation 4.29
Change From Baseline in Serum Bicarbonate by Hour 66 Hours	3.7 mmol/L Standard Deviation 6.49	2.6 mmol/L Standard Deviation 5.02
Change From Baseline in Serum Bicarbonate by Hour 72 Hours	4.2 mmol/L Standard Deviation 6.59	0.1 mmol/L Standard Deviation 6.68
Change From Baseline in Serum Bicarbonate by Hour 78 Hours	2.8 mmol/L Standard Deviation 5.01	2.9 mmol/L Standard Deviation 5.46
Change From Baseline in Serum Bicarbonate by Hour 84 Hours	3.3 mmol/L Standard Deviation 5.48	2.5 mmol/L Standard Deviation 5.34
Change From Baseline in Serum Bicarbonate by Hour 90 Hours	3.3 mmol/L Standard Deviation 6.05	2.2 mmol/L Standard Deviation 5.26
Change From Baseline in Serum Bicarbonate by Hour 96 Hours	2.8 mmol/L Standard Deviation 5.88	1.4 mmol/L Standard Deviation 5.81
Change From Baseline in Serum Bicarbonate by Hour 102 Hours	2.2 mmol/L Standard Deviation 5.64	-1.1 mmol/L Standard Deviation 7.48
Change From Baseline in Serum Bicarbonate by Hour 108 Hours	2.7 mmol/L Standard Deviation 5.25	-0.4 mmol/L Standard Deviation 7.67
Change From Baseline in Serum Bicarbonate by Hour 114 Hours	3.8 mmol/L Standard Deviation 6.2	-2.8 mmol/L Standard Deviation 8
Change From Baseline in Serum Bicarbonate by Hour 120 Hours	2.8 mmol/L Standard Deviation 5.94	-1.5 mmol/L Standard Deviation 7.13

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in pH by Hour 108 Hours	0 pH Standard Deviation 0.11	0.1 pH Standard Deviation 0.16
Change From Baseline in pH by Hour 6 Hours	-0.0 pH Standard Deviation 0.06	0.1 pH Standard Deviation 0.09
Change From Baseline in pH by Hour 12 Hours	-0.0 pH Standard Deviation 0.07	0.1 pH Standard Deviation 0.1
Change From Baseline in pH by Hour 18 Hours	0 pH Standard Deviation 0.1	0 pH Standard Deviation 0.11
Change From Baseline in pH by Hour 24 Hours	0 pH Standard Deviation 0.1	0 pH Standard Deviation 0.1
Change From Baseline in pH by Hour 30 Hours	0 pH Standard Deviation 0.1	0.1 pH Standard Deviation 0.11
Change From Baseline in pH by Hour 36 Hours	0 pH Standard Deviation 0.11	0.1 pH Standard Deviation 0.1
Change From Baseline in pH by Hour 42 Hours	0 pH Standard Deviation 0.11	0.1 pH Standard Deviation 0.09
Change From Baseline in pH by Hour 48 Hours	0 pH Standard Deviation 0.12	0.1 pH Standard Deviation 0.1
Change From Baseline in pH by Hour 54 Hours	0 pH Standard Deviation 0.13	0.1 pH Standard Deviation 0.09
Change From Baseline in pH by Hour 60 Hours	0 pH Standard Deviation 0.14	0.1 pH Standard Deviation 0.08
Change From Baseline in pH by Hour 66 Hours	0.1 pH Standard Deviation 0.16	0 pH Standard Deviation 0.07
Change From Baseline in pH by Hour 72 Hours	0 pH Standard Deviation 0.13	0 pH Standard Deviation 0.16
Change From Baseline in pH by Hour 78 Hours	0 pH Standard Deviation 0.13	0.1 pH Standard Deviation 0.11
Change From Baseline in pH by Hour 84 Hours	0.1 pH Standard Deviation 0.12	0.1 pH Standard Deviation 0.09
Change From Baseline in pH by Hour 90 Hours	0 pH Standard Deviation 0.14	0.1 pH Standard Deviation 0.1
Change From Baseline in pH by Hour 96 Hours	0 pH Standard Deviation 0.16	0.1 pH Standard Deviation 0.14
Change From Baseline in pH by Hour 102 Hours	0 pH Standard Deviation 0.12	0 pH Standard Deviation 0.11
Change From Baseline in pH by Hour 114 Hours	0 pH Standard Deviation 0.12	-0.0 pH Standard Deviation 0.12
Change From Baseline in pH by Hour 120 Hours	-0.0 pH Standard Deviation 0.12	0 pH Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Base Excess by Hour 6 Hours	0.4 mmol/L Standard Deviation 6.92	1.1 mmol/L Standard Deviation 4.72
Change From Baseline in Base Excess by Hour 12 Hours	-1.3 mmol/L Standard Deviation 5.06	1.7 mmol/L Standard Deviation 4.75
Change From Baseline in Base Excess by Hour 18 Hours	0.3 mmol/L Standard Deviation 7.28	1.1 mmol/L Standard Deviation 6.08
Change From Baseline in Base Excess by Hour 24 Hours	2.4 mmol/L Standard Deviation 6.65	0.6 mmol/L Standard Deviation 6.15
Change From Baseline in Base Excess by Hour 30 Hours	1.3 mmol/L Standard Deviation 5.64	1.7 mmol/L Standard Deviation 5.91
Change From Baseline in Base Excess by Hour 36 Hours	3 mmol/L Standard Deviation 7.36	0.9 mmol/L Standard Deviation 5.74
Change From Baseline in Base Excess by Hour 42 Hours	2.8 mmol/L Standard Deviation 7.41	2.1 mmol/L Standard Deviation 6.09
Change From Baseline in Base Excess by Hour 48 Hours	2.4 mmol/L Standard Deviation 6.87	1.9 mmol/L Standard Deviation 5.67
Change From Baseline in Base Excess by Hour 54 Hours	1.3 mmol/L Standard Deviation 6.99	0.4 mmol/L Standard Deviation 5.78
Change From Baseline in Base Excess by Hour 60 Hours	3.7 mmol/L Standard Deviation 7.57	1.2 mmol/L Standard Deviation 7.26
Change From Baseline in Base Excess by Hour 66 Hours	3.2 mmol/L Standard Deviation 8.43	2.1 mmol/L Standard Deviation 5.2
Change From Baseline in Base Excess by Hour 72 Hours	3.6 mmol/L Standard Deviation 7.5	-2.1 mmol/L Standard Deviation 12.94
Change From Baseline in Base Excess by Hour 78 Hours	2.5 mmol/L Standard Deviation 5.77	4 mmol/L Standard Deviation 5.98
Change From Baseline in Base Excess by Hour 84 Hours	4 mmol/L Standard Deviation 6.61	3.7 mmol/L Standard Deviation 5.27
Change From Baseline in Base Excess by Hour 90 Hours	3 mmol/L Standard Deviation 5.98	3.1 mmol/L Standard Deviation 5.53
Change From Baseline in Base Excess by Hour 96 Hours	3.5 mmol/L Standard Deviation 7.29	2.2 mmol/L Standard Deviation 5.91
Change From Baseline in Base Excess by Hour 102 Hours	1.6 mmol/L Standard Deviation 5.56	-1.0 mmol/L Standard Deviation 9.04
Change From Baseline in Base Excess by Hour 108 Hours	3.5 mmol/L Standard Deviation 5.95	0.8 mmol/L Standard Deviation 9.34
Change From Baseline in Base Excess by Hour 114 Hours	2.7 mmol/L Standard Deviation 5.72	-2.8 mmol/L Standard Deviation 9.47
Change From Baseline in Base Excess by Hour 120 Hours	2.8 mmol/L Standard Deviation 7.23	-2.0 mmol/L Standard Deviation 8.94

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Blood Total Calcium Concentration by Hour 1 Hour	-0.0 mmol/L Standard Deviation 0.12	-0.0 mmol/L Standard Deviation 0.13
Change From Baseline in Blood Total Calcium Concentration by Hour 6 Hours	0.1 mmol/L Standard Deviation 0.21	-0.0 mmol/L Standard Deviation 0.14
Change From Baseline in Blood Total Calcium Concentration by Hour 12 Hours	0.2 mmol/L Standard Deviation 0.27	-0.0 mmol/L Standard Deviation 0.19
Change From Baseline in Blood Total Calcium Concentration by Hour 18 Hours	0.2 mmol/L Standard Deviation 0.25	-0.0 mmol/L Standard Deviation 0.22
Change From Baseline in Blood Total Calcium Concentration by Hour 24 Hours	0.3 mmol/L Standard Deviation 0.24	-0.1 mmol/L Standard Deviation 0.31
Change From Baseline in Blood Total Calcium Concentration by Hour 30 Hours	0.3 mmol/L Standard Deviation 0.22	-0.0 mmol/L Standard Deviation 0.22
Change From Baseline in Blood Total Calcium Concentration by Hour 36 Hours	0.3 mmol/L Standard Deviation 0.24	-0.1 mmol/L Standard Deviation 0.24
Change From Baseline in Blood Total Calcium Concentration by Hour 42 Hours	0.3 mmol/L Standard Deviation 0.28	-0.1 mmol/L Standard Deviation 0.22
Change From Baseline in Blood Total Calcium Concentration by Hour 48 Hours	0.3 mmol/L Standard Deviation 0.26	-0.1 mmol/L Standard Deviation 0.27
Change From Baseline in Blood Total Calcium Concentration by Hour 54 Hours	0.3 mmol/L Standard Deviation 0.24	-0.1 mmol/L Standard Deviation 0.25
Change From Baseline in Blood Total Calcium Concentration by Hour 60 Hours	0.3 mmol/L Standard Deviation 0.24	-0.1 mmol/L Standard Deviation 0.24
Change From Baseline in Blood Total Calcium Concentration by Hour 66 Hours	0.3 mmol/L Standard Deviation 0.27	-0.1 mmol/L Standard Deviation 0.26
Change From Baseline in Blood Total Calcium Concentration by Hour 72 Hours	0.3 mmol/L Standard Deviation 0.27	-0.1 mmol/L Standard Deviation 0.26
Change From Baseline in Blood Total Calcium Concentration by Hour 78 Hours	0.3 mmol/L Standard Deviation 0.29	-0.1 mmol/L Standard Deviation 0.24
Change From Baseline in Blood Total Calcium Concentration by Hour 84 Hours	0.3 mmol/L Standard Deviation 0.33	-0.2 mmol/L Standard Deviation 0.27
Change From Baseline in Blood Total Calcium Concentration by Hour 90 Hours	0.3 mmol/L Standard Deviation 0.35	-0.1 mmol/L Standard Deviation 0.27
Change From Baseline in Blood Total Calcium Concentration by Hour 96 Hours	0.2 mmol/L Standard Deviation 0.27	-0.2 mmol/L Standard Deviation 0.27
Change From Baseline in Blood Total Calcium Concentration by Hour 102 Hours	0.2 mmol/L Standard Deviation 0.27	-0.1 mmol/L Standard Deviation 0.29
Change From Baseline in Blood Total Calcium Concentration by Hour 108 Hours	0.3 mmol/L Standard Deviation 0.35	-0.1 mmol/L Standard Deviation 0.29
Change From Baseline in Blood Total Calcium Concentration by Hour 114 Hours	0.2 mmol/L Standard Deviation 0.27	-0.2 mmol/L Standard Deviation 0.25
Change From Baseline in Blood Total Calcium Concentration by Hour 120 Hours	0.4 mmol/L Standard Deviation 0.2	-0.1 mmol/L Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Sodium by Hour 6 Hours	-1.1 mmol/L Standard Deviation 2.89	0.4 mmol/L Standard Deviation 1.89
Change From Baseline in Serum Sodium by Hour 12 Hours	-1.6 mmol/L Standard Deviation 2.06	-0.1 mmol/L Standard Deviation 3.01
Change From Baseline in Serum Sodium by Hour 18 Hours	-1.7 mmol/L Standard Deviation 2.13	0.5 mmol/L Standard Deviation 3.39
Change From Baseline in Serum Sodium by Hour 24 Hours	-1.7 mmol/L Standard Deviation 4.19	0.4 mmol/L Standard Deviation 4.35
Change From Baseline in Serum Sodium by Hour 30 Hours	-1.9 mmol/L Standard Deviation 4.03	0.4 mmol/L Standard Deviation 4.83
Change From Baseline in Serum Sodium by Hour 36 Hours	-1.1 mmol/L Standard Deviation 5.13	-0.3 mmol/L Standard Deviation 5.08
Change From Baseline in Serum Sodium by Hour 42 Hours	-0.7 mmol/L Standard Deviation 5.15	-0.4 mmol/L Standard Deviation 5.04
Change From Baseline in Serum Sodium by Hour 48 Hours	-1.5 mmol/L Standard Deviation 5.74	1.2 mmol/L Standard Deviation 4.47
Change From Baseline in Serum Sodium by Hour 54 Hours	-1.3 mmol/L Standard Deviation 6.29	0.5 mmol/L Standard Deviation 4.95
Change From Baseline in Serum Sodium by Hour 60 Hours	-1.3 mmol/L Standard Deviation 5.86	1 mmol/L Standard Deviation 4.99
Change From Baseline in Serum Sodium by Hour 66 Hours	-0.7 mmol/L Standard Deviation 6.1	0.3 mmol/L Standard Deviation 4.11
Change From Baseline in Serum Sodium by Hour 72 Hours	-0.8 mmol/L Standard Deviation 5.62	2.5 mmol/L Standard Deviation 4.61
Change From Baseline in Serum Sodium by Hour 78 Hours	-1.8 mmol/L Standard Deviation 5.21	2.6 mmol/L Standard Deviation 4.06
Change From Baseline in Serum Sodium by Hour 84 Hours	-2.2 mmol/L Standard Deviation 4.95	1.7 mmol/L Standard Deviation 4.87
Change From Baseline in Serum Sodium by Hour 90 Hours	-1.8 mmol/L Standard Deviation 4.17	2.2 mmol/L Standard Deviation 4.47
Change From Baseline in Serum Sodium by Hour 96 Hours	-2.0 mmol/L Standard Deviation 4.51	2.3 mmol/L Standard Deviation 3.24
Change From Baseline in Serum Sodium by Hour 102 Hours	-1.8 mmol/L Standard Deviation 4.9	1.1 mmol/L Standard Deviation 3.53
Change From Baseline in Serum Sodium by Hour 108 Hours	-2.4 mmol/L Standard Deviation 4.36	0.7 mmol/L Standard Deviation 3.73
Change From Baseline in Serum Sodium by Hour 114 Hours	-2.8 mmol/L Standard Deviation 4.78	1.4 mmol/L Standard Deviation 4.12
Change From Baseline in Serum Sodium by Hour 120 Hours	-3.7 mmol/L Standard Deviation 4.39	1 mmol/L Standard Deviation 5.16

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Anion Gap by Hour 6 Hours	0.6 mmol/L Standard Deviation 3.08	-2.3 mmol/L Standard Deviation 2.27
Change From Baseline in Serum Anion Gap by Hour 12 Hours	0.6 mmol/L Standard Deviation 2.45	-3.5 mmol/L Standard Deviation 3.1
Change From Baseline in Serum Anion Gap by Hour 18 Hours	0.2 mmol/L Standard Deviation 2.96	-2.2 mmol/L Standard Deviation 4.72
Change From Baseline in Serum Anion Gap by Hour 24 Hours	-0.5 mmol/L Standard Deviation 3.07	-2.9 mmol/L Standard Deviation 3.24
Change From Baseline in Serum Anion Gap by Hour 30 Hours	1.6 mmol/L Standard Deviation 3.08	-3.6 mmol/L Standard Deviation 3.55
Change From Baseline in Serum Anion Gap by Hour 36 Hours	0.5 mmol/L Standard Deviation 3.41	-4 mmol/L Standard Deviation 2.73
Change From Baseline in Serum Anion Gap by Hour 42 Hours	0.7 mmol/L Standard Deviation 3.33	-3.5 mmol/L Standard Deviation 2.9
Change From Baseline in Serum Anion Gap by Hour 48 Hours	0.7 mmol/L Standard Deviation 3.7	-2.8 mmol/L Standard Deviation 3.21
Change From Baseline in Serum Anion Gap by Hour 54 Hours	0.3 mmol/L Standard Deviation 3.47	-3.2 mmol/L Standard Deviation 3.27
Change From Baseline in Serum Anion Gap by Hour 60 Hours	0.4 mmol/L Standard Deviation 3.58	-2.3 mmol/L Standard Deviation 3.67
Change From Baseline in Serum Anion Gap by Hour 66 Hours	1.1 mmol/L Standard Deviation 4	-3.2 mmol/L Standard Deviation 4.37
Change From Baseline in Serum Anion Gap by Hour 72 Hours	1 mmol/L Standard Deviation 4.37	0 mmol/L Standard Deviation 5.93
Change From Baseline in Serum Anion Gap by Hour 78 Hours	0.7 mmol/L Standard Deviation 2.39	-2.0 mmol/L Standard Deviation 3.4
Change From Baseline in Serum Anion Gap by Hour 84 Hours	0.8 mmol/L Standard Deviation 2.74	-3.0 mmol/L Standard Deviation 3.91
Change From Baseline in Serum Anion Gap by Hour 90 Hours	0.8 mmol/L Standard Deviation 3.59	-2.1 mmol/L Standard Deviation 3.54
Change From Baseline in Serum Anion Gap by Hour 96 Hours	1.6 mmol/L Standard Deviation 2.35	-1.7 mmol/L Standard Deviation 4.21
Change From Baseline in Serum Anion Gap by Hour 102 Hours	1.5 mmol/L Standard Deviation 2.54	-1.7 mmol/L Standard Deviation 5.15
Change From Baseline in Serum Anion Gap by Hour 108 Hours	0.8 mmol/L Standard Deviation 2.67	0.6 mmol/L Standard Deviation 5.44
Change From Baseline in Serum Anion Gap by Hour 114 Hours	1 mmol/L Standard Deviation 2.71	0.7 mmol/L Standard Deviation 8.64
Change From Baseline in Serum Anion Gap by Hour 120 Hours	-0.3 mmol/L Standard Deviation 2.06	-1.2 mmol/L Standard Deviation 7.03

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Magnesium by Hour 6 Hours	-0.1 mmol/L Standard Deviation 0.12	0 mmol/L Standard Deviation 0.14
Change From Baseline in Serum Magnesium by Hour 12 Hours	-0.1 mmol/L Standard Deviation 0.14	-0.0 mmol/L Standard Deviation 0.14
Change From Baseline in Serum Magnesium by Hour 18 Hours	-0.1 mmol/L Standard Deviation 0.19	0 mmol/L Standard Deviation 0.14
Change From Baseline in Serum Magnesium by Hour 24 Hours	-0.2 mmol/L Standard Deviation 0.2	-0.0 mmol/L Standard Deviation 0.16
Change From Baseline in Serum Magnesium by Hour 30 Hours	-0.1 mmol/L Standard Deviation 0.23	0 mmol/L Standard Deviation 0.17
Change From Baseline in Serum Magnesium by Hour 36 Hours	-0.1 mmol/L Standard Deviation 0.22	0 mmol/L Standard Deviation 0.19
Change From Baseline in Serum Magnesium by Hour 42 Hours	-0.2 mmol/L Standard Deviation 0.23	0 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 48 Hours	-0.2 mmol/L Standard Deviation 0.25	0.1 mmol/L Standard Deviation 0.16
Change From Baseline in Serum Magnesium by Hour 54 Hours	-0.2 mmol/L Standard Deviation 0.21	0 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 60 Hours	-0.1 mmol/L Standard Deviation 0.23	0 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 66 Hours	-0.1 mmol/L Standard Deviation 0.24	0 mmol/L Standard Deviation 0.18
Change From Baseline in Serum Magnesium by Hour 72 Hours	-0.1 mmol/L Standard Deviation 0.22	0.1 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 78 Hours	-0.2 mmol/L Standard Deviation 0.21	0.1 mmol/L Standard Deviation 0.16
Change From Baseline in Serum Magnesium by Hour 84 Hours	-0.2 mmol/L Standard Deviation 0.22	0 mmol/L Standard Deviation 0.18
Change From Baseline in Serum Magnesium by Hour 90 Hours	-0.2 mmol/L Standard Deviation 0.27	0.1 mmol/L Standard Deviation 0.21
Change From Baseline in Serum Magnesium by Hour 96 Hours	-0.2 mmol/L Standard Deviation 0.24	0.1 mmol/L Standard Deviation 0.18
Change From Baseline in Serum Magnesium by Hour 102 Hours	-0.2 mmol/L Standard Deviation 0.23	0.1 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 108 Hours	-0.2 mmol/L Standard Deviation 0.28	0.1 mmol/L Standard Deviation 0.2
Change From Baseline in Serum Magnesium by Hour 114 Hours	-0.1 mmol/L Standard Deviation 0.27	0.1 mmol/L Standard Deviation 0.23
Change From Baseline in Serum Magnesium by Hour 120 Hours	-0.2 mmol/L Standard Deviation 0.28	0 mmol/L Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Phosphate by Hour 6 Hours	-0.3 mmol/L Standard Deviation 0.33	-0.4 mmol/L Standard Deviation 0.29
Change From Baseline in Serum Phosphate by Hour 12 Hours	-0.3 mmol/L Standard Deviation 0.51	-0.4 mmol/L Standard Deviation 0.32
Change From Baseline in Serum Phosphate by Hour 18 Hours	-0.5 mmol/L Standard Deviation 0.7	-0.4 mmol/L Standard Deviation 0.41
Change From Baseline in Serum Phosphate by Hour 24 Hours	-0.7 mmol/L Standard Deviation 0.74	-0.4 mmol/L Standard Deviation 0.36
Change From Baseline in Serum Phosphate by Hour 30 Hours	-0.6 mmol/L Standard Deviation 0.7	-0.5 mmol/L Standard Deviation 0.35
Change From Baseline in Serum Phosphate by Hour 36 Hours	-0.7 mmol/L Standard Deviation 0.78	-0.4 mmol/L Standard Deviation 0.32
Change From Baseline in Serum Phosphate by Hour 42 Hours	-0.8 mmol/L Standard Deviation 0.82	-0.5 mmol/L Standard Deviation 0.32
Change From Baseline in Serum Phosphate by Hour 48 Hours	-0.9 mmol/L Standard Deviation 0.87	-0.4 mmol/L Standard Deviation 0.33
Change From Baseline in Serum Phosphate by Hour 54 Hours	-0.8 mmol/L Standard Deviation 0.86	-0.4 mmol/L Standard Deviation 0.43
Change From Baseline in Serum Phosphate by Hour 60 Hours	-0.9 mmol/L Standard Deviation 0.93	-0.4 mmol/L Standard Deviation 0.41
Change From Baseline in Serum Phosphate by Hour 66 Hours	-0.8 mmol/L Standard Deviation 0.89	-0.4 mmol/L Standard Deviation 0.52
Change From Baseline in Serum Phosphate by Hour 72 Hours	-0.8 mmol/L Standard Deviation 0.88	-0.2 mmol/L Standard Deviation 0.74
Change From Baseline in Serum Phosphate by Hour 78 Hours	-0.8 mmol/L Standard Deviation 0.86	-0.4 mmol/L Standard Deviation 0.55
Change From Baseline in Serum Phosphate by Hour 84 Hours	-0.8 mmol/L Standard Deviation 0.84	-0.4 mmol/L Standard Deviation 0.48
Change From Baseline in Serum Phosphate by Hour 90 Hours	-0.8 mmol/L Standard Deviation 0.84	-0.3 mmol/L Standard Deviation 0.71
Change From Baseline in Serum Phosphate by Hour 96 Hours	-0.8 mmol/L Standard Deviation 0.92	-0.5 mmol/L Standard Deviation 0.6
Change From Baseline in Serum Phosphate by Hour 102 Hours	-0.7 mmol/L Standard Deviation 0.85	-0.4 mmol/L Standard Deviation 0.63
Change From Baseline in Serum Phosphate by Hour 108 Hours	-0.8 mmol/L Standard Deviation 0.84	-0.4 mmol/L Standard Deviation 0.76
Change From Baseline in Serum Phosphate by Hour 114 Hours	-0.9 mmol/L Standard Deviation 0.91	0.2 mmol/L Standard Deviation 0.77
Change From Baseline in Serum Phosphate by Hour 120 Hours	-0.8 mmol/L Standard Deviation 1.02	-0.2 mmol/L Standard Deviation 0.86

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Potassium by Hour 6 Hours	-0.4 mmol/L Standard Deviation 0.62	-0.1 mmol/L Standard Deviation 0.56
Change From Baseline in Serum Potassium by Hour 12 Hours	-0.4 mmol/L Standard Deviation 0.66	-0.1 mmol/L Standard Deviation 0.51
Change From Baseline in Serum Potassium by Hour 18 Hours	-0.7 mmol/L Standard Deviation 0.68	-0.1 mmol/L Standard Deviation 0.43
Change From Baseline in Serum Potassium by Hour 24 Hours	-0.9 mmol/L Standard Deviation 0.75	-0.2 mmol/L Standard Deviation 0.49
Change From Baseline in Serum Potassium by Hour 30 Hours	-0.9 mmol/L Standard Deviation 0.7	-0.1 mmol/L Standard Deviation 0.67
Change From Baseline in Serum Potassium by Hour 36 Hours	-1.0 mmol/L Standard Deviation 0.81	-0.0 mmol/L Standard Deviation 0.69
Change From Baseline in Serum Potassium by Hour 42 Hours	-1.0 mmol/L Standard Deviation 0.68	-0.0 mmol/L Standard Deviation 0.58
Change From Baseline in Serum Potassium by Hour 48 Hours	-1.0 mmol/L Standard Deviation 0.62	-0.0 mmol/L Standard Deviation 0.54
Change From Baseline in Serum Potassium by Hour 54 Hours	-1.2 mmol/L Standard Deviation 0.61	0.1 mmol/L Standard Deviation 0.65
Change From Baseline in Serum Potassium by Hour 60 Hours	-1.2 mmol/L Standard Deviation 0.76	0.1 mmol/L Standard Deviation 0.54
Change From Baseline in Serum Potassium by Hour 66 Hours	-1.2 mmol/L Standard Deviation 0.81	0.3 mmol/L Standard Deviation 0.58
Change From Baseline in Serum Potassium by Hour 72 Hours	-1.2 mmol/L Standard Deviation 0.69	0.2 mmol/L Standard Deviation 0.83
Change From Baseline in Serum Potassium by Hour 78 Hours	-1.2 mmol/L Standard Deviation 0.75	0.1 mmol/L Standard Deviation 0.68
Change From Baseline in Serum Potassium by Hour 84 Hours	-1.3 mmol/L Standard Deviation 0.77	0.2 mmol/L Standard Deviation 0.65
Change From Baseline in Serum Potassium by Hour 90 Hours	-1.4 mmol/L Standard Deviation 0.71	0.2 mmol/L Standard Deviation 0.75
Change From Baseline in Serum Potassium by Hour 96 Hours	-1.1 mmol/L Standard Deviation 0.85	0.2 mmol/L Standard Deviation 0.82
Change From Baseline in Serum Potassium by Hour 102 Hours	-1.2 mmol/L Standard Deviation 0.72	0 mmol/L Standard Deviation 0.73
Change From Baseline in Serum Potassium by Hour 108 Hours	-1.2 mmol/L Standard Deviation 0.76	0.1 mmol/L Standard Deviation 0.86
Change From Baseline in Serum Potassium by Hour 114 Hours	-1.5 mmol/L Standard Deviation 0.8	0.2 mmol/L Standard Deviation 0.85
Change From Baseline in Serum Potassium by Hour 120 Hours	-1.1 mmol/L Standard Deviation 0.63	0.1 mmol/L Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Serum Chloride by Hour 60 Hours	-5.9 mmol/L Standard Deviation 7.68	1 mmol/L Standard Deviation 4.79
Change From Baseline in Serum Chloride by Hour 66 Hours	-5.3 mmol/L Standard Deviation 7.82	1 mmol/L Standard Deviation 4.94
Change From Baseline in Serum Chloride by Hour 72 Hours	-5.6 mmol/L Standard Deviation 7.61	1.7 mmol/L Standard Deviation 4.38
Change From Baseline in Serum Chloride by Hour 78 Hours	-5.5 mmol/L Standard Deviation 7.4	2.4 mmol/L Standard Deviation 4.45
Change From Baseline in Serum Chloride by Hour 84 Hours	-5.8 mmol/L Standard Deviation 6.76	2.1 mmol/L Standard Deviation 5.33
Change From Baseline in Serum Chloride by Hour 90 Hours	-5.9 mmol/L Standard Deviation 7.68	2.3 mmol/L Standard Deviation 5.1
Change From Baseline in Serum Chloride by Hour 96 Hours	-6.2 mmol/L Standard Deviation 7.69	2.4 mmol/L Standard Deviation 4.64
Change From Baseline in Serum Chloride by Hour 102 Hours	-6.0 mmol/L Standard Deviation 7.51	2.6 mmol/L Standard Deviation 6.02
Change From Baseline in Serum Chloride by Hour 108 Hours	-5.9 mmol/L Standard Deviation 7.88	1.3 mmol/L Standard Deviation 4.42
Change From Baseline in Serum Chloride by Hour 114 Hours	-7.7 mmol/L Standard Deviation 8.63	1.1 mmol/L Standard Deviation 5.96
Change From Baseline in Serum Chloride by Hour 120 Hours	-8.1 mmol/L Standard Deviation 6.28	1 mmol/L Standard Deviation 5.89
Change From Baseline in Serum Chloride by Hour 6 Hours	-1.9 mmol/L Standard Deviation 4.12	0.6 mmol/L Standard Deviation 3.1
Change From Baseline in Serum Chloride by Hour 12 Hours	-3.4 mmol/L Standard Deviation 4.23	0.9 mmol/L Standard Deviation 3.44
Change From Baseline in Serum Chloride by Hour 18 Hours	-3.9 mmol/L Standard Deviation 5.67	0.8 mmol/L Standard Deviation 3.52
Change From Baseline in Serum Chloride by Hour 24 Hours	-3.9 mmol/L Standard Deviation 6.58	1.3 mmol/L Standard Deviation 5.04
Change From Baseline in Serum Chloride by Hour 30 Hours	-5.5 mmol/L Standard Deviation 6.84	1.1 mmol/L Standard Deviation 4.59
Change From Baseline in Serum Chloride by Hour 36 Hours	-5.0 mmol/L Standard Deviation 6.73	0.6 mmol/L Standard Deviation 4.44
Change From Baseline in Serum Chloride by Hour 42 Hours	-4.9 mmol/L Standard Deviation 7.31	0.5 mmol/L Standard Deviation 4.5
Change From Baseline in Serum Chloride by Hour 48 Hours	-5.1 mmol/L Standard Deviation 7.35	1.3 mmol/L Standard Deviation 4.44
Change From Baseline in Serum Chloride by Hour 54 Hours	-5.4 mmol/L Standard Deviation 7.39	0.9 mmol/L Standard Deviation 4.91

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Number of Participants With Bleeding Events 0 Bleeding Events	16 Participants	13 Participants
Number of Participants With Bleeding Events 1 Bleeding Events	1 Participants	3 Participants
Number of Participants With Bleeding Events 2 Bleeding Events	0 Participants	0 Participants
Number of Participants With Bleeding Events 4 Bleeding Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Number of Participants by Number of Blood Transfusions 3 Transfusions	1 participants	2 participants
Number of Participants by Number of Blood Transfusions 27 Transfusions	0 participants	1 participants

SECONDARY outcome

Timeframe: Up to 30 days post study CRRT treatment completion

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)	0 Events	1 Events

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Blood Pressure at Last Visit Systolic	1.9 mmHg Standard Deviation 25.37	-6.4 mmHg Standard Deviation 30.99
Change From Baseline in Blood Pressure at Last Visit Diastolic	-2.8 mmHg Standard Deviation 12.29	2.8 mmHg Standard Deviation 21.19

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Respiratory Rate at Last Visit	-2.1 breaths/Min Standard Deviation 5.42	-1.1 breaths/Min Standard Deviation 7.64

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Temperature at Last Visit	0.2 degree celsius Standard Deviation 0.69	-0.1 degree celsius Standard Deviation 1.12

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Pulse at Last Visit	2.1 beats/min Standard Deviation 24.66	3.2 beats/min Standard Deviation 16.52

SECONDARY outcome

Timeframe: Baseline and up to 120 hours post CRRT treatment initiation

Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Change From Baseline in Total Calcium/iCa Ratio by Hour 1 Hour	0.2 ratio Standard Deviation 0.25	-0.1 ratio Standard Deviation 0.12
Change From Baseline in Total Calcium/iCa Ratio by Hour 6 Hours	0.2 ratio Standard Deviation 0.17	-0.1 ratio Standard Deviation 0.12
Change From Baseline in Total Calcium/iCa Ratio by Hour 12 Hours	0.2 ratio Standard Deviation 0.18	-0.1 ratio Standard Deviation 0.12
Change From Baseline in Total Calcium/iCa Ratio by Hour 18 Hours	0.2 ratio Standard Deviation 0.13	-0.1 ratio Standard Deviation 0.1
Change From Baseline in Total Calcium/iCa Ratio by Hour 24 Hours	0.3 ratio Standard Deviation 0.25	-0.1 ratio Standard Deviation 0.08
Change From Baseline in Total Calcium/iCa Ratio by Hour 30 Hours	0.2 ratio Standard Deviation 0.16	-0.1 ratio Standard Deviation 0.09
Change From Baseline in Total Calcium/iCa Ratio by Hour 36 Hours	0.2 ratio Standard Deviation 0.14	-0.1 ratio Standard Deviation 0.08
Change From Baseline in Total Calcium/iCa Ratio by Hour 42 Hours	0.3 ratio Standard Deviation 0.21	-0.1 ratio Standard Deviation 0.08
Change From Baseline in Total Calcium/iCa Ratio by Hour 48 Hours	0.2 ratio Standard Deviation 0.2	-0.1 ratio Standard Deviation 0.07
Change From Baseline in Total Calcium/iCa Ratio by Hour 54 Hours	0.2 ratio Standard Deviation 0.18	-0.1 ratio Standard Deviation 0.1
Change From Baseline in Total Calcium/iCa Ratio by Hour 60 Hours	0.2 ratio Standard Deviation 0.16	-0.1 ratio Standard Deviation 0.09
Change From Baseline in Total Calcium/iCa Ratio by Hour 66 Hours	0.2 ratio Standard Deviation 0.19	-0.1 ratio Standard Deviation 0.09
Change From Baseline in Total Calcium/iCa Ratio by Hour 72 Hours	0.2 ratio Standard Deviation 0.16	-0.1 ratio Standard Deviation 0.1
Change From Baseline in Total Calcium/iCa Ratio by Hour 78 Hours	0.2 ratio Standard Deviation 0.23	-0.1 ratio Standard Deviation 0.13
Change From Baseline in Total Calcium/iCa Ratio by Hour 84 Hours	0.2 ratio Standard Deviation 0.18	-0.1 ratio Standard Deviation 0.09
Change From Baseline in Total Calcium/iCa Ratio by Hour 90 Hours	0.2 ratio Standard Deviation 0.18	-0.1 ratio Standard Deviation 0.11
Change From Baseline in Total Calcium/iCa Ratio by Hour 96 Hours	0.2 ratio Standard Deviation 0.2	-0.1 ratio Standard Deviation 0.11
Change From Baseline in Total Calcium/iCa Ratio by Hour 102 Hours	0.2 ratio Standard Deviation 0.2	-0.1 ratio Standard Deviation 0.11
Change From Baseline in Total Calcium/iCa Ratio by Hour 108 Hours	0.2 ratio Standard Deviation 0.19	-0.1 ratio Standard Deviation 0.14
Change From Baseline in Total Calcium/iCa Ratio by Hour 114 Hours	0.1 ratio Standard Deviation 0.17	-0.1 ratio Standard Deviation 0.11
Change From Baseline in Total Calcium/iCa Ratio by Hour 120 Hours	0.2 ratio Standard Deviation 0.14	-0.1 ratio Standard Deviation 0.09

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Number of Bleeding Events by Location Gastrointestinal	1 Events	4 Events
Number of Bleeding Events by Location M150 filter	0 Events	1 Events
Number of Bleeding Events by Location ostomy and rectum	0 Events	1 Events
Number of Bleeding Events by Location upper Gastrointestinal tract	0 Events	1 Events

SECONDARY outcome

Timeframe: Up to 120 hours post CRRT treatment initiation

Population: FAS

Outcome measures

Measure	Prismocitrate 18 n=17 Participants CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 Participants CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Duration of Bleeding Events	0 Hours Standard Deviation 0	14.4 Hours Standard Deviation 12.71

Adverse Events

Prismocitrate 18

Serious events: 10 serious events

Other events: 13 other events

Deaths: 8 deaths

No Systemic Anticoagulation

Serious events: 10 serious events

Other events: 14 other events

Deaths: 9 deaths

Serious adverse events

Measure	Prismocitrate 18 n=17 participants at risk CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 participants at risk CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Cardiac disorders Cardiac arrest	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	11.8% 2/17 • Number of events 3 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Cardio-respiratory arrest	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Cardiogenic shock	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Nodal arrhythmia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Intestinal perforation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
General disorders Cardiac death	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation
General disorders Death	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Fungaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Septic shock	23.5% 4/17 • Number of events 5 • Up to 120 hours post CRRT treatment initiation	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Injury, poisoning and procedural complications Fall	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Investigations Blood lactic acid increased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood pH decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Haematocrit decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Nervous system disorders Cerebrovascular accident	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Renal and urinary disorders Acute kidney injury	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	17.6% 3/17 • Number of events 3 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Hypovolaemic shock	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Peripheral ischaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation

Other adverse events

Measure	Prismocitrate 18 n=17 participants at risk CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).	No Systemic Anticoagulation n=17 participants at risk CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period).
Blood and lymphatic system disorders Anaemia	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Arrhythmia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Atrial fibrillation	35.3% 6/17 • Number of events 6 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Atrial flutter	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Bradycardia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Tachycardia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Cardiac disorders Ventricular tachycardia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Congenital, familial and genetic disorders Hypophosphatasia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Eye disorders Macular degeneration	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Dysphagia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Faecaloma	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Haematemesis	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
General disorders Eye complication associated with device	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
General disorders Fatigue	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
General disorders Oedema	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
General disorders Pyrexia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
General disorders Therapeutic response decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Immune system disorders Drug hypersensitivity	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Pneumonia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Postoperative wound infection	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Injury, poisoning and procedural complications Skin wound	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood bicarbonate decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood bilirubin increased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood chloride decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood lactic acid increased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood phosphorus decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Blood pressure decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Haematocrit decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Haemoglobin decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation
Investigations Hepatic enzyme abnormal	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations PCO2 decreased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Investigations Radial pulse abnormal	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Investigations White blood cell count increased	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Acidosis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hyperkalaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypocalcaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	17.6% 3/17 • Number of events 4 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypokalaemia	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypomagnesaemia	17.6% 3/17 • Number of events 3 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypophosphataemia	11.8% 2/17 • Number of events 2 • Up to 120 hours post CRRT treatment initiation	23.5% 4/17 • Number of events 4 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Hypovolaemia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Ketoacidosis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Metabolism and nutrition disorders Lactic acidosis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Nervous system disorders Hypoaesthesia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Nervous system disorders Unresponsive to stimuli	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Renal and urinary disorders Anuria	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Renal and urinary disorders Haematuria	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Hypercapnia	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Skin and subcutaneous tissue disorders Blister	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Skin and subcutaneous tissue disorders Erythema multiforme	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Axillary vein thrombosis	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Haemorrhage	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Hypertension	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	5.9% 1/17 • Number of events 1 • Up to 120 hours post CRRT treatment initiation
Vascular disorders Hypotension	0.00% 0/17 • Up to 120 hours post CRRT treatment initiation	17.6% 3/17 • Number of events 3 • Up to 120 hours post CRRT treatment initiation

Additional Information

Global CORP Clinical Trials Disclosure

Vantive

Phone: +1 2249484283

Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
• Publication restrictions are in place

Restriction type: OTHER