| Primary | Delivered UFnet Rates. | A minimum separation of 0.53-0.57 mL/kg/h in mean delivered UFnet rates between the two intervention arms. | 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. | Posted | | Median | Inter-Quartile Range | mL/kg/h | | Until the end of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.48(1.00 to 1.94)
- OG0011.57(0.93 to 2.17)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | GLMM | | 0.5 | | | | | | | | | | | | | | Other | | |
|
| Primary | No. of Participants With Protocol Deviation. | 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. | 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. | Posted | | Count of Participants | | Participants | | Until the end of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Primary | Participant Recruitment/ICU/ 2 Months | An enrollment rate of 1 patient per ICU per time period. | Participant recruitment rate per ICU per 2 months during an overall recruitment period lasting 24 months across both treatment arms. | Posted | | Mean | Standard Deviation | participant/ ICU/ 2 months | | 24 months | ICUs | ICUs | | ID | Title | Description |
|---|
| OG000 | Liberal UFnet Strategy | No. of participants recruited per ICU per 2 months | | OG001 | Restrictive UFnet Strategy | No. of participants recruited per ICU per 2 months |
| |
| Secondary | Daily Fluid Balance (Average) | Patient daily fluid balance will be measured while on continuous kidney replacement therapy and reported as average across all study days. | 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. | Posted | | Median | Inter-Quartile Range | mL | | Average daily fluid balance from enrollment to ICU discharge or until day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Cumulative Fluid Balance | Patient cumulative fluid balance will be measured while on continuous kidney replacement therapy. | 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. | Posted | | Median | Inter-Quartile Range | mL | | Daily from enrollment to ICU discharge or until day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Duration of Kidney Replacement Therapy | The number of days the patient received kidney replacement therapy while in the hospital. | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Median | Inter-Quartile Range | days | | Daily from enrollment to hospital discharge or until day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Duration of Mechanical Ventilation | The number of days the patient received mechanical ventilation while in hospital. | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Median | Inter-Quartile Range | days | | Daily from study enrollment to ICU discharge or until day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Organ Failure Free Days | The no. of days the patient remained free of organ failure while in the ICU. | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Mean | Standard Deviation | days | | Daily from study enrollment to ICU discharge or until day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | ICU Length of Stay | The number of days patients need to stay in the ICU | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Median | Inter-Quartile Range | days | | Daily from study enrollment to ICU discharge or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Hospital Length of Stay | The number of days patients need to stay in the hospital | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Median | Inter-Quartile Range | days | | Daily from study enrollment to hospital discharge or day 28. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Hospital Mortality | The proportion of patients who died while in the hospital. | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment to hospital discharge or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Secondary | Dependence on Kidney Replacement Therapy | The proportion of patients who were on dialysis at hospital discharge. | The secondary outcome was compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until hospital discharge or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Intradialytic Hypotension Episodes | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Mean | Standard Deviation | episodes per patient per day | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Intradialytic Hypertension Episodes | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Mean | Standard Deviation | episodes per patient per day | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Episodes of Intradialytic Cardiac Arrhythmias | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Mean | Standard Deviation | episodes per patient per day | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants Who Receive UFnet Rates Higher Than the Assigned Intervention Arm for Treatment of Fluid Overload Emergencies. | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Severe Hypophosphatemia | Hypophosphatemia defined by serum phosphate <0.5 mg/dL | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Severe Hypokalemia | Hypokalemia defined by serum potassium <3.0 mg/dL | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Severe Hypocalcemia | Hypocalcemia defined by serum calcium <1.90 mg/dL or ionized calcium <0.90 mmol/L | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Episodes of Stopping of CKRT System Due to Hemofilter Clotting or Clogging. | Stopping of CKRT system due to filter clotting and/or clogging. | The adverse events were compared among participants assigned to the two groups. | Posted | | Number | | Number of episodes | | From study enrollment until termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Discontinuation of Fluid Removal Due to Hemodynamic Instability. | No. of participants in whom fluid removal is stopped due to hemodynamic instability such as intradialytic hypotension, cardiac arrhythmias, or cardiac arrest. | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants in Whom Surgical Wounds Are Left Open After Surgery Due to Tissue Edema. | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With New Organ Dysfunction as Assessed by Change in Sequential Organ Failure Assessement (SOFA) Scoring System From Baseline. | 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. | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Worsening of Systolic or Diastolic Cardiac Function on Echocardiogram From Baseline. | Changes in transthoracic echocardiogram will be assessed from baseline (if available) | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Worsening of Pulmonary Edema on Chest X Ray and/or CT Scan Based on Radiologist Report. | Changes in chest X ray and CT scan will be assessed from baseline (if available). | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Worsening of Ileus on Abdominal X Ray and/or CT Scan Based on Radiologist Report. | Changes in abdominal X ray and CT scan will be assessed from baseline (if available) | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Bowel Ischemia or Anastomotic Breakdown Based on Intraoperative Findings. | Intraoperative findings of bowel ischemia or anastomotic breakdown will be noted as determined by the surgeon (if available). | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With Pressure Ulceration Per Nursing Records. | No. of participants with new diagnosis of pressure ulcerations as documented by the nursing staff in the electronic medical record (if available) | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
| |
| Other Pre-specified | No. of Participants With New Wound Infection Per Nursing Records. | No. of participants with new diagnosis of wound infection as documented by the nursing staff in the electronic medical record (if available) | | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
|---|
| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
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| Other Pre-specified | No. of Participants With New Arterial and/or Deep Vein Thrombosis as Assessed by Doppler Studies. | New arterial thrombosis or deep vein thrombosis as assessed by doppler study (if available) | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
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| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
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| Other Pre-specified | No. of Participants With Severe Anemia Requiring Red Cell Transfusions. | Participants with severe anemia requiring red cell transfusions (if available). | | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
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| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
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| Other Pre-specified | No. of Participants With Severe Thrombocytopenia Requiring Platelet Transfusions. | No. of participants with severe thrombocytopenia requiring platelet transfusions (if available). | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
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| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
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| Other Pre-specified | No. of Participants With New Secondary Infections. | 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). | The adverse events were compared among participants assigned to the two groups. | Posted | | Count of Participants | | Participants | | From study enrollment until 24 hours after termination of continuous kidney replacement therapy or day 28, whichever occurs first. | | | | ID | Title | Description |
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| OG000 | Restrictive UFnet Strategy | 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. | | OG001 | Liberal UFnet Strategy | 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. |
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