Use of Intravenous Albumin in Nephrology Practice Should Be Guideline-Based.
Emma K Ullrich, Jeannie Callum, Edward G Clark
https://pubmed.ncbi.nlm.nih.gov/40305120/Actively Recruiting
Led by Ottawa Hospital Research Institute · Updated on 2025-05-01
856
Participants Needed
16
Research Sites
8 weeks
Total Duration
Researchers are evaluating the use of intravenous hyperoncotic albumin compared to normal saline boluses in critically ill patients suffering from Acute Kidney Injury requiring renal replacement therapy AKI-RRT. This trial aims to determine whether albumin administration during renal replacement therapy sessions increases organ support-free days and renal replacement therapy-free days within 28 days after randomization. The study addresses the challenge that renal replacement therapy, while life-saving, may cause complications like hypotension and organ ischemia in these patients. Participants will be randomly assigned to receive either 20-25% albumin fluid or normal saline boluses during their renal replacement therapy sessions in the intensive care unit. Each treatment involves two 100 mL boluses one at the start and one halfway through each session. The renal replacement therapies include continuous renal replacement therapy CRRT, prolonged intermittent renal replacement therapy PIRRT, or intermittent hemodialysis IHD. Treatments will continue for up to 14 days in the ICU, with dosing schedules tailored to the type of renal replacement therapy. During the study, participants will be closely monitored for organ support-free days, renal replacement therapy-free days, and other health outcomes through 28 days, with extended follow-up for mortality and kidney function up to 365 days. Researchers will collect data on fluid balance, hypotension episodes during therapy, organ function scores, healthcare costs, and quality of life measures. The trial involves multiple intensive care units and includes comprehensive assessments to evaluate the impact and safety of albumin use in this critical condition.
CONDITIONS
Albumin To Enhance Recovery After Acute Kidney Injury
E
Edward G Clark, MD MSc FRCPC
I
Irene Watpool, RN BScN
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Ottawa Hospital Research Institute
Lead Sponsor
The Physicians' Services Incorporated Foundation
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive randomized boluses of either albumin or normal saline during their renal replacement therapy sessions in the ICU.
RRT sessions as determined by the treating physician, with boluses at the start and halfway through each session
Duration - Up to 365 days
Participants are monitored for outcomes including organ support-free days, mortality, renal function, and quality of life through 365 days following randomization.
Visits and assessments through 365 days following randomization
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Emma K Ullrich, Jeannie Callum, Edward G Clark
https://pubmed.ncbi.nlm.nih.gov/40305120/Ottawa Hospital Research Institute
Lead Sponsor
The Physicians' Services Incorporated Foundation
Collaborating Sponsor