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Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury
NA trial testing Restrictive UFnet Rate Strategy in Acute Kidney Injury in 99 participants. Terminated before completion.
| Lead sponsor | University of Pittsburgh |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 99 |
| Start date | 5 July 2022 |
| Primary completion | 17 June 2024 |
| Estimated completion | 26 June 2024 |
| Sites | 2 locations across United States |
University of Pittsburgh
18 and older, any sex, with Acute Kidney Injury or Fluid Overload. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A minimum separation of 0.53-0.57 mL/kg/h in mean delivered UFnet rates between the two intervention arms.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 1.48 | 1.00 – 1.94 |
| Liberal UFnet Strategy | 1.57 | 0.93 – 2.17 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 4 | |
| Liberal UFnet Strategy | 5 |
An enrollment rate of 1 patient per ICU per time period.
| Group | Value | 95% CI |
|---|---|---|
| Liberal UFnet Strategy | 2.33 | ± 2.11 |
| Restrictive UFnet Strategy | 1.79 | ± 1.88 |
Patient daily fluid balance will be measured while on continuous kidney replacement therapy and reported as average across all study days.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 44 | -1187 – 1202.20 |
| Liberal UFnet Strategy | -53 | -1119.6 – 937.3 |
Patient cumulative fluid balance will be measured while on continuous kidney replacement therapy.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 229 | -5983 – 7030.8 |
| Liberal UFnet Strategy | 1280.1 | -7390.8 – 6060.4 |
The number of days the patient received kidney replacement therapy while in the hospital.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 7 | 4 – 17 |
| Liberal UFnet Strategy | 5 | 2 – 11 |
The number of days the patient received mechanical ventilation while in hospital.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 2 | 0 – 6 |
| Liberal UFnet Strategy | 3 | 0 – 7 |
The no. of days the patient remained free of organ failure while in the ICU.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 3.90 | ± 8.5 |
| Liberal UFnet Strategy | 3.92 | ± 7.9 |
The number of days patients need to stay in the ICU
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 8 | 4.5 – 15.5 |
| Liberal UFnet Strategy | 8 | 4 – 16 |
The number of days patients need to stay in the hospital
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 22.5 | 9 – 28 |
| Liberal UFnet Strategy | 16 | 5 – 28 |
The proportion of patients who died while in the hospital.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 9 | |
| Liberal UFnet Strategy | 23 |
The proportion of patients who were on dialysis at hospital discharge.
| Group | Value | 95% CI |
|---|---|---|
| Restrictive UFnet Strategy | 16 | |
| Liberal UFnet Strategy | 12 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Restrictive UFnet Strategy | Liberal UFnet Strategy |
|---|---|---|---|
| Death after transition to comfort measures | General disorders | — | — |
| Prolonged inpatient hospitalization | General disorders | — | — |
| Multisystem organ failure resulting in death | General disorders | — | — |
| Subdural hematoma | Vascular disorders | — | — |
| Cardiopulmonary arrest | Cardiac disorders | — | — |
| End Stage Renal Disease | Renal and urinary disorders | — | — |
| Hypoxemic respiratory failure requiring intubation | Respiratory, thoracic and mediastinal disorders | — | — |
| New small bowel obstruction | General disorders | — | — |
| Worsening acidosis and hypotension despite up-escalation of pressors | General disorders | — | — |
| GI hemorrhage | Gastrointestinal disorders | — | — |
| Undifferentiated shock and hypertensive cardiomyopathy | General disorders | — | — |
| Hemorrhagic and hypovolemic shock secondary to massive hematemesis from GE varices. | Gastrointestinal disorders | — | — |
| Reaction | System | Restrictive UFnet Strategy | Liberal UFnet Strategy |
|---|---|---|---|
| Intradialytic hypotension | Cardiac disorders | — | — |
| New organ dysfunction | General disorders | — | — |
| Use of rescue net ultrafiltration | Renal and urinary disorders | — | — |
| Severe anemia | Blood and lymphatic system disorders | — | — |
| UFNET discontinuation due to instability | Renal and urinary disorders | — | — |
| Hemofilter clotting or clogging | General disorders | — | — |
| Intradialytic hypertension | Cardiac disorders | — | — |
| Severe thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Cardiac arrhythmias | Cardiac disorders | — | — |
| Worsening of pulmonary edema | Respiratory, thoracic and mediastinal disorders | — | — |
| New secondary infections | Infections and infestations | — | — |
| Severe hypokalemia (<3.0 mg/dL) | Metabolism and nutrition disorders | — | — |
| Severe hypocalcemia (<1.90 mg/dL) | Metabolism and nutrition disorders | — | — |
| Bowel ischemia or anastomotic breakdown | Gastrointestinal disorders | — | — |
| New pressure ulcerations | Skin and subcutaneous tissue disorders | — | — |
| New wound infections | Skin and subcutaneous tissue disorders | — | — |
| New arterial thrombosis | Vascular disorders | — | — |
| New venous thrombosis | Vascular disorders | — | — |
| Severe hypophosphatemia (<0.5 mg/dL) | Metabolism and nutrition disorders | — | — |
| Surgical wounds edema | Injury, poisoning and procedural complications | — | — |
| Worsening cardiac function | Cardiac disorders | — | — |
| Worsening of ileus | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Death after transition to comfort measures, Prolonged inpatient hospitalization, Multisystem organ failure resulting in death, Subdural hematoma, Cardiopulmonary arrest, End Stage Renal Disease, Hypoxemic respiratory failure requiring intubation, New small bowel obstruction.
Data from ClinicalTrials.gov NCT05306964 adverse events section.
Critically ill patients with acute kidney injury and fluid overload who are frequently treated by fluid removal during dialysis are at an increased risk of complications and death. Both slower and faster rates of fluid removal may cause injury to the vital organs. This proposed clinical trial will examine the feasibility of restrictive compared with a liberal rate of fluid removal in order to develop effective treatments for fluid overload and to improve the health of critically ill patients.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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