Status:
TERMINATED
Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Acute Kidney Injury
Fluid Overload
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fas...
Detailed Description
"Net ultrafiltration (UFnet)," also known as net fluid removal during kidney replacement therapy, has been used in the treatment of fluid overload among critically ill patients with acute kidney injur...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Stage 3 acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
- Started or intending to start CKRT for volume management
- Attending intensivist or nephrologist intending to remove net fluid using CKRT for at least 48 hours
Exclusion
- Respiratory distress due to pulmonary edema or fluid overload in unintubated patients
- Massive volume infusion (i.e., \>200 mL/h for \>6 hours of continuous infusion)
- No intention to remove net fluid as determined by attending intensivist or nephrologist
- Attending intensivist or nephrologist believes that the protocol will not be followed
- Continuous net fluid removal for \>48 hours prior to study enrollment
- Patients on chronic outpatient hemodialysis
- Patients with history of, or current admission for kidney transplantation
- Patients on comfort measures only orders.
- Moribund not expected to survive \>24 hours
- Confirmed pregnancy
- Patients treated with extracorporeal membrane oxygenation, ventricular assist device, or intra-aortic balloon pump
- Organ donors with neurological determination of death (i.e., brain dead donors)
- Drug overdose requiring CKRT for drug clearance
- Enrollment in a concurrent interventional clinical trial with direct impact on fluid balance (e.g., \>500 mL study drug administration)
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT05306964
Start Date
July 5 2022
End Date
June 26 2024
Last Update
August 29 2025
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261