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Albumin To Enhance Recovery After Acute Kidney Injury
Sponsor: Ottawa Hospital Research Institute
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.
Official title: Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
856
Start Date
2023-11-02
Completion Date
2025-10-23
Last Updated
2025-05-01
Healthy Volunteers
No
Interventions
20-25% Albumin fluid (100 mL)
Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).
0.9% Normal Saline (100 mL)
Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomization then every 12 hours while continuing on CRRT).
Locations (16)
The Governors of the University of Calgary
Calgary, Alberta, Canada
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Sunnybrook Health Sciences Centre
North York, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Scarborough Health Network
Scarborough Village, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
Lakeridge Health
Whitby, Ontario, Canada
Centre Integre de Sante et de Services Sociaux de Laval
Laval, Quebec, Canada
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada