Trial Outcomes & Findings for Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children (NCT NCT02561247)

NCT ID: NCT02561247

Last Updated: 2025-07-14

Results Overview

Blood Urea Nitrogen (BUN)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 24 hours from CRRT initiation
• Results posted on: 2025-07-14

Participant Flow

Participant milestones

Measure	Prismaflex HF20 CRRT Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Prismaflex HF20 CRRT Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1
Overall Study Two filter changes required within the first 24 hours.	4

Baseline Characteristics

Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

Baseline characteristics by cohort

Measure	Prismaflex HF20 CRRT n=23 Participants Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Age, Continuous	40.6 months STANDARD_DEVIATION 21.47 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours from CRRT initiation

Population: The full analysis set (FAS) was based on the intent-to-treat (ITT) principle and includes any patient who received CRRT on the Prismaflex HF20 Set for any period of time. Number of subjects (n=17) with evaluable data is shown, which is a subset of FAS (N=23).

Blood Urea Nitrogen (BUN)

Outcome measures

Measure	Prismaflex HF20 CRRT n=17 Participants Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT	-58.118 Percent Change Standard Deviation 20.0848

SECONDARY outcome

Timeframe: 24 hours from CRRT initiation

Population: FAS. Number of subjects (n) with evaluable data is shown.

Outcome measures

Measure	Prismaflex HF20 CRRT n=17 Participants Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT	-45.687 Percent Change Standard Deviation 19.8848

SECONDARY outcome

Timeframe: 24 hours from CRRT initiation

Population: FAS. Number of subjects (n) with evaluable data is shown.

Outcome measures

Measure	Prismaflex HF20 CRRT n=17 Participants Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT	38.287 Percent Change Standard Deviation 29.6885

SECONDARY outcome

Timeframe: Up to 72 Hours after Initiation

Population: FAS

Filters that were replaced any time CRRT was stopped for reasons other than the failure to mediate the two alarms specified were censored at their current duration of usage (filter clotted and TMP excessive). Only filters that were replaced due to the two alarms were considered events for this survival analysis. A total of 34 filters were used in the study and 22 filters were censored, leaving data from only 12 filters to complete the survival estimate. Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached. Filter life of filters were analyzed using a Kaplan Meier survival curve with quartile survival times after the start of CRRT.

Outcome measures

Measure	Prismaflex HF20 CRRT n=34 filters Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
HF20 Set Filter Survival Time 25th Percentile	11.79 hours Interval 5.07 to 68.09
HF20 Set Filter Survival Time 50th Percentile	NA hours Interval 18.65 to Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached.
HF20 Set Filter Survival Time 75th Percentile	NA hours Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were not reached.

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 72 hours from CRRT initiation

Population: FAS

The end of the extracorporeal circuit life will be defined by the occurrence of one or both of the following Prismaflex ® System alarms, after which CRRT will be terminated and the extracorporeal circuit replaced:

• Warning: Filter is Clotted, and/or
• Caution: TMP (Trans Membrane Pressure) Excessive

Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms:

• Caution: Flow Problem
• Caution: Gain Limit Reached
• Caution: Loss Limit Reached

Outcome measures

Measure	Prismaflex HF20 CRRT n=23 Participants Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Alarm: Warning Filter Clotted	7 participants
Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Alarm: Caution TMP Excessive	1 participants
Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Alarm: Caution Flow Problem	13 participants
Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Alarm: Warning Loss Limit Reached	0 participants
Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Alarm: Warning Gain Limit Reached	0 participants

Adverse Events

Prismaflex HF20 CRRT

Serious events: 5 serious events

Other events: 16 other events

Deaths: 2 deaths

Serious adverse events

Measure	Prismaflex HF20 CRRT n=23 participants at risk Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Cardiac disorders Cardiac Arrest	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Cardiac disorders Right Ventricular Failure	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders Hypercalcaemia	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Nervous system disorders Intraventricular Haemorrhage	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertensive Crisis	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Vascular disorders Peripheral Ischaemia	4.3% 1/23 • Number of events 1 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours

Other adverse events

Measure	Prismaflex HF20 CRRT n=23 participants at risk Patients included in this arm will be treated for a minimum period of 24 hours and up to 72 hours with each Prismaflex® HF 20 Set being measured for statistical analysis at 12 hour intervals during CRRT treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Cardiac disorders BRADYCARDIA	13.0% 3/23 • Number of events 3 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
General disorders HYPOTHERMIA	17.4% 4/23 • Number of events 4 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Hepatobiliary disorders HEPATIC FAILURE	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Injury, poisoning and procedural complications CITRATE TOXICITY	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders HYPERCALCAEMIA	17.4% 4/23 • Number of events 4 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders HYPOKALAEMIA	26.1% 6/23 • Number of events 6 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders HYPOMAGNESAEMIA	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	13.0% 3/23 • Number of events 3 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Metabolism and nutrition disorders LACTIC ACIDOSIS	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Psychiatric disorders AGITATION	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	8.7% 2/23 • Number of events 2 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Vascular disorders HYPERTENSION	17.4% 4/23 • Number of events 4 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours
Vascular disorders HYPOTENSION	13.0% 3/23 • Number of events 3 • Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours

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 Baxter Healthcare Corporation 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