Trial Outcomes & Findings for Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (NCT NCT05306964)
NCT ID: NCT05306964
Last Updated: 2025-08-29
Results Overview
A minimum separation of 0.53-0.57 mL/kg/h in mean delivered UFnet rates between the two intervention arms.
TERMINATED
NA
99 participants
Until the end of continuous kidney replacement therapy or day 28, whichever occurs first.
2025-08-29
Participant Flow
RELIEVE AKI is a multicenter, prospective randomized controlled trial. This study enrolled 99 patients into the study between July 5, 2022 - June 17, 2024 at UPMC and Mayo Clinic hospitals.
For this study, time of signing the informed consent will be the study enrollment time. There is no patient-level randomization in this trial. The randomization is at the ICU-level and based on study period of every two months.
Participant milestones
| Measure |
Sequence 1 (ICU-1)
22 months of Liberal UFnet strategy followed by 1 month of Restrictive UFnet strategy.
|
Sequence 2 (ICU-2)
20 months of Liberal UFnet strategy followed by 3 months of Restrictive UFnet strategy.
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Sequence 3 (ICU-3)
14 months of Liberal UFnet strategy and 9 months of Restrictive UFnet strategy.
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Sequence 4 (ICU-4)
8 months of Liberal UFnet strategy and 15 months of Restrictive UFnet strategy.
|
Sequence 5 (ICU-5)
23 months of Liberal UFnet strategy and 0 months of Restrictive UFnet strategy.
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Sequence 6 (ICU-6)
12 months of Liberal UFnet strategy and 11 months of Restrictive UFnet strategy.
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Sequence 7 (ICU-7)
18 months of Liberal UFnet strategy and 5 months of Restrictive UFnet strategy.
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Sequence 8 (ICU-8)
6 months of Liberal UFnet strategy and 17 months of Restrictive UFnet strategy.
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Sequence 9 (ICU-9)
10 months of Liberal UFnet strategy and 13 months of Restrictive UFnet strategy.
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Sequence 10 (ICU-10)
16 months of Liberal UFnet strategy and 7 months of Restrictive UFnet strategy.
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
59 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until the end of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The primary outcome was assessed among participants assigned to the Liberal and Restrictive UFnet strategies. Even though the unit of randomization is the ICU, the outcomes were assessed only among participants.
A minimum separation of 0.53-0.57 mL/kg/h in mean delivered UFnet rates between the two intervention arms.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Delivered UFnet Rates.
|
1.48 mL/kg/h
Interval 1.0 to 1.94
|
1.57 mL/kg/h
Interval 0.93 to 2.17
|
PRIMARY outcome
Timeframe: Until the end of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The primary outcome was assessed among participants assigned to the Liberal and Restrictive UFnet strategies. Even though the unit of randomization is the ICU, the outcomes were assessed only among participants.
Protocol deviation defined as delivered UFnet rate that lies \>0.5 mL/kg/h outside of the target UFnet rate range for greater than six consecutive hours.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Protocol Deviation.
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Participant recruitment rate per ICU per 2 months during an overall recruitment period lasting 24 months across both treatment arms.
An enrollment rate of 1 patient per ICU per time period.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=10 ICUs
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=9 ICUs
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Participant Recruitment/ICU/ 2 Months
|
2.33 participant/ ICU/ 2 months
Standard Deviation 2.11
|
1.79 participant/ ICU/ 2 months
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Average daily fluid balance from enrollment to ICU discharge or until day 28, whichever occurs first.Population: The outcome measure is the average of daily fluid balance (i.e., fluid input minus output over 24 hours) while the patient stayed in the ICU and was compared between the two groups.
Patient daily fluid balance will be measured while on continuous kidney replacement therapy and reported as average across all study days.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Daily Fluid Balance (Average)
|
44 mL
Interval -1187.0 to 1202.2
|
-53 mL
Interval -1119.6 to 937.3
|
SECONDARY outcome
Timeframe: Daily from enrollment to ICU discharge or until day 28, whichever occurs first.Population: This is the cumulative fluid balance (i.e., cumulative fluid input minus output for all days a patient was in the ICU) and was compared between the two groups.
Patient cumulative fluid balance will be measured while on continuous kidney replacement therapy.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Cumulative Fluid Balance
|
229 mL
Interval -5983.0 to 7030.8
|
1280.1 mL
Interval -7390.8 to 6060.4
|
SECONDARY outcome
Timeframe: Daily from enrollment to hospital discharge or until day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The number of days the patient received kidney replacement therapy while in the hospital.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Duration of Kidney Replacement Therapy
|
7 days
Interval 4.0 to 17.0
|
5 days
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: Daily from study enrollment to ICU discharge or until day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The number of days the patient received mechanical ventilation while in hospital.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
2 days
Interval 0.0 to 6.0
|
3 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Daily from study enrollment to ICU discharge or until day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The no. of days the patient remained free of organ failure while in the ICU.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Organ Failure Free Days
|
3.90 days
Standard Deviation 8.5
|
3.92 days
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Daily from study enrollment to ICU discharge or day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The number of days patients need to stay in the ICU
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
ICU Length of Stay
|
8 days
Interval 4.5 to 15.5
|
8 days
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: Daily from study enrollment to hospital discharge or day 28.Population: The secondary outcome was compared among participants assigned to the two groups.
The number of days patients need to stay in the hospital
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Hospital Length of Stay
|
22.5 days
Interval 9.0 to 28.0
|
16 days
Interval 5.0 to 28.0
|
SECONDARY outcome
Timeframe: From study enrollment to hospital discharge or day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The proportion of patients who died while in the hospital.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Hospital Mortality
|
9 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From study enrollment until hospital discharge or day 28, whichever occurs first.Population: The secondary outcome was compared among participants assigned to the two groups.
The proportion of patients who were on dialysis at hospital discharge.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Dependence on Kidney Replacement Therapy
|
16 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Intradialytic hypotension will be defined as a new mean arterial pressure \<65 mmHg, systolic blood pressure \<90 mmHg or a decline in systolic blood pressure \>40 mmHg, and/or a \>30% increase in dose of existing vasopressors, initiating a new vasopressor, or administration of fluid bolus with a goal to maintain mean arterial pressure \>=65 mmHg, systolic blood pressure \>=90 mmHg.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Intradialytic Hypotension Episodes
|
1.16 episodes per patient per day
Standard Deviation 0.34
|
1.20 episodes per patient per day
Standard Deviation 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28.Population: The adverse events were compared among participants assigned to the two groups.
Intradialytic hypertension will be defined as new onset systolic blood pressure \>=160 mmHg or mean arterial pressure \>=80 mmHg for more than 1 hour in the absence of any vasopressor or inotrope use.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Intradialytic Hypertension Episodes
|
1 episodes per patient per day
Standard Deviation 0
|
1.05 episodes per patient per day
Standard Deviation 0.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
New onset intradialytic cardiac arrhythmias including supraventricular tachycardia, bradycardia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation, asystole/pulseless electrical activity will be diagnosed as per American Heart Association.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Episodes of Intradialytic Cardiac Arrhythmias
|
0.83 episodes per patient per day
Standard Deviation 0.29
|
0.92 episodes per patient per day
Standard Deviation 0.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
No. of participants in whom emergent use of UFnet rates higher than the assigned treatment arm for more than 3 consecutive hours will be noted.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants Who Receive UFnet Rates Higher Than the Assigned Intervention Arm for Treatment of Fluid Overload Emergencies.
|
27 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Hypophosphatemia defined by serum phosphate \<0.5 mg/dL
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Severe Hypophosphatemia
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Hypokalemia defined by serum potassium \<3.0 mg/dL
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Severe Hypokalemia
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Hypocalcemia defined by serum calcium \<1.90 mg/dL or ionized calcium \<0.90 mmol/L
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Severe Hypocalcemia
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Stopping of CKRT system due to filter clotting and/or clogging.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Episodes of Stopping of CKRT System Due to Hemofilter Clotting or Clogging.
|
34 Number of episodes
|
39 Number of episodes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
No. of participants in whom fluid removal is stopped due to hemodynamic instability such as intradialytic hypotension, cardiac arrhythmias, or cardiac arrest.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Discontinuation of Fluid Removal Due to Hemodynamic Instability.
|
21 Participants
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
This will be determined as per the primary surgeon. Abdominal wounds left open for a second look or for abdominal re-exploration will not be counted unless there is concurrent tissue edema precluding abdominal closure.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants in Whom Surgical Wounds Are Left Open After Surgery Due to Tissue Edema.
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
New organ dysfunction will be assessed by changes in SOFA scores from the baseline across the five organ systems of central nervous system, cardiovascular, respiratory, coagulation, and liver.
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With New Organ Dysfunction as Assessed by Change in Sequential Organ Failure Assessement (SOFA) Scoring System From Baseline.
|
19 Participants
|
33 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Changes in transthoracic echocardiogram will be assessed from baseline (if available)
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Worsening of Systolic or Diastolic Cardiac Function on Echocardiogram From Baseline.
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Changes in chest X ray and CT scan will be assessed from baseline (if available).
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Worsening of Pulmonary Edema on Chest X Ray and/or CT Scan Based on Radiologist Report.
|
4 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Changes in abdominal X ray and CT scan will be assessed from baseline (if available)
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Worsening of Ileus on Abdominal X Ray and/or CT Scan Based on Radiologist Report.
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
Intraoperative findings of bowel ischemia or anastomotic breakdown will be noted as determined by the surgeon (if available).
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Bowel Ischemia or Anastomotic Breakdown Based on Intraoperative Findings.
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
No. of participants with new diagnosis of pressure ulcerations as documented by the nursing staff in the electronic medical record (if available)
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Pressure Ulceration Per Nursing Records.
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.No. of participants with new diagnosis of wound infection as documented by the nursing staff in the electronic medical record (if available)
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With New Wound Infection Per Nursing Records.
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
New arterial thrombosis or deep vein thrombosis as assessed by doppler study (if available)
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With New Arterial and/or Deep Vein Thrombosis as Assessed by Doppler Studies.
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Participants with severe anemia requiring red cell transfusions (if available).
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Severe Anemia Requiring Red Cell Transfusions.
|
16 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
No. of participants with severe thrombocytopenia requiring platelet transfusions (if available).
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With Severe Thrombocytopenia Requiring Platelet Transfusions.
|
6 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first.Population: The adverse events were compared among participants assigned to the two groups.
New diagnosis of secondary infections occurring after initiation of study intervention will be collected based on culture data, antibiotic use and suspected sepsis as per clinician judgment (if available).
Outcome measures
| Measure |
Restrictive UFnet Strategy
n=41 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=54 Participants
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
No. of Participants With New Secondary Infections.
|
3 Participants
|
4 Participants
|
Adverse Events
Restrictive UFnet Strategy
Liberal UFnet Strategy
Serious adverse events
| Measure |
Restrictive UFnet Strategy
n=43 participants at risk
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=56 participants at risk
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
General disorders
Prolonged inpatient hospitalization
|
7.0%
3/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
7.1%
4/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
Death after transition to comfort measures
|
16.3%
7/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
23.2%
13/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Vascular disorders
Subdural hematoma
|
4.7%
2/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemic respiratory failure requiring intubation
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
New small bowel obstruction
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
3.6%
2/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
Multisystem organ failure resulting in death
|
4.7%
2/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
7.1%
4/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
Worsening acidosis and hypotension despite up-escalation of pressors
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Gastrointestinal disorders
GI hemorrhage
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
Undifferentiated shock and hypertensive cardiomyopathy
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Gastrointestinal disorders
Hemorrhagic and hypovolemic shock secondary to massive hematemesis from GE varices.
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
Other adverse events
| Measure |
Restrictive UFnet Strategy
n=43 participants at risk
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Restrictive UFnet Rate Strategy: In the restrictive group, the UFnet rate will be titrated between 0.5-1.5 mL/kg/h and maintained throughout fluid removal.
|
Liberal UFnet Strategy
n=56 participants at risk
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Liberal UFnet Rate Strategy: In the liberal group, the UFnet rate will be titrated between 2.0-5.0 mL/kg/h and maintained throughout fluid removal.
|
|---|---|---|
|
Cardiac disorders
Intradialytic hypotension
|
72.1%
31/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
76.8%
43/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Cardiac disorders
Intradialytic hypertension
|
20.9%
9/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
28.6%
16/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Cardiac disorders
Cardiac arrhythmias
|
7.0%
3/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
21.4%
12/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Renal and urinary disorders
Use of rescue net ultrafiltration
|
62.8%
27/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
14.3%
8/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Metabolism and nutrition disorders
Severe hypophosphatemia (<0.5 mg/dL)
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Metabolism and nutrition disorders
Severe hypokalemia (<3.0 mg/dL)
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Metabolism and nutrition disorders
Severe hypocalcemia (<1.90 mg/dL)
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
Hemofilter clotting or clogging
|
41.9%
18/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
37.5%
21/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Renal and urinary disorders
UFNET discontinuation due to instability
|
48.8%
21/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
42.9%
24/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Injury, poisoning and procedural complications
Surgical wounds edema
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
General disorders
New organ dysfunction
|
44.2%
19/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
58.9%
33/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Cardiac disorders
Worsening cardiac function
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of pulmonary edema
|
9.3%
4/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
10.7%
6/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Gastrointestinal disorders
Worsening of ileus
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Gastrointestinal disorders
Bowel ischemia or anastomotic breakdown
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Skin and subcutaneous tissue disorders
New pressure ulcerations
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Skin and subcutaneous tissue disorders
New wound infections
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Vascular disorders
New arterial thrombosis
|
2.3%
1/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
0.00%
0/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Vascular disorders
New venous thrombosis
|
0.00%
0/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
1.8%
1/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Blood and lymphatic system disorders
Severe anemia
|
37.2%
16/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
46.4%
26/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Blood and lymphatic system disorders
Severe thrombocytopenia
|
14.0%
6/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
26.8%
15/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
|
Infections and infestations
New secondary infections
|
7.0%
3/43 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
7.1%
4/56 • Adverse events for this study were collected from study enrollment until 24 hours after termination of continuous kidney replacement therapy, up to a maximum time frame of 28 days. For example, if continuous kidney replacement therapy was terminated on day 14 on a patient, adverse events were collected until day 15. If continuous kidney replacement therapy continued beyond 28 days, the adverse events were collected only up to 28 days.
|
Additional Information
Raghavan Murugan, MD, MS, FRCP, Principal Investigator
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place