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/40305120Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04705896
Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial
Led by Ottawa Hospital Research Institute · Updated on 2025-05-01
856
Participants Needed
16
Research Sites
8 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
T
The Physicians' Services Incorporated Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Albumin To Enhance Recovery After Acute Kidney Injury
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admitted to a critical care or intensive care unit for more than 24 hours
- Receiving vasoactive therapy and/or mechanical ventilation, including non-invasive ventilation
- Immediate start of renal replacement therapy planned or additional sessions planned for acute kidney injury
You will not qualify if you...
- Starting renal replacement therapy for reasons other than acute kidney injury
- Known end-stage kidney disease before hospitalization
- Kidney transplant within the past year
- Having or suspected of having renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy, or acute interstitial nephritis
- Advanced cirrhosis (Child Pugh class C), spontaneous bacterial peritonitis, or hepatorenal syndrome
- Using acute peritoneal dialysis as the first renal replacement therapy
- Contraindications to albumin including traumatic brain injury, increased intracranial pressure, history of anaphylaxis to albumin, or objection to albumin/blood transfusions
- Already received two or more renal replacement therapy sessions during current ICU stay
- Medical limitations preventing renal replacement therapy, mechanical ventilation, vasoactive medications, or plans for palliative care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 16 locations
1
The Governors of the University of Calgary
Calgary, Alberta, Canada
Not Yet Recruiting
2
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, Canada
Not Yet Recruiting
3
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Not Yet Recruiting
4
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Actively Recruiting
5
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
6
Sunnybrook Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Actively Recruiting
7
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
8
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
9
Scarborough Health Network
Scarborough Village, Ontario, Canada
Not Yet Recruiting
10
Niagara Health System
St. Catharines, Ontario, Canada, L2S0A9
Actively Recruiting
11
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
12
Sinai Health System
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
13
Lakeridge Health
Whitby, Ontario, Canada, L1N 6K9
Not Yet Recruiting
14
Centre Integre de Sante et de Services Sociaux de Laval
Laval, Quebec, Canada, H7M3L9
Actively Recruiting
15
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Actively Recruiting
16
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Not Yet Recruiting
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Research Team
E
Edward G Clark, MD MSc FRCPC
I
Irene Watpool, RN BScN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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