Clinical Trial

Albumin To Enhance Recovery After Acute Kidney Injury

Study acronym: ALTER-AKI
Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated May 1, 2025 (before its estimated August 28, 2025 completion). Its status may not reflect the trial's current state.
Summary
Study objectives: To determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control/placebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to: 1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and 2. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-01-09; most recent amendment 2025-04-30.
Status change: Not Yet Recruiting → Recruiting 2023-10-30
Trial Details
NCT Number NCT04705896
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: The Physicians' Services Incorporated Foundation, The Kidney Foundation of Canada, The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant., Canadian Institutes of Health Research (CIHR), Canadian Blood Services, Héma-Québec
Conditions Acute Kidney Injury, Renal Replacement Therapy, Hypotension, Critical Illness
Enrollment 856 participants
Start Date 2023-11-02
Primary Completion 2025-08-28 (estimated)
Study Completion 2025-10-23 (estimated)
Updated on ClinicalTrials.gov 2025-05-01