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RECRUITING
NCT04705896
PHASE4

Albumin To Enhance Recovery After Acute Kidney Injury

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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

BIOLOGICAL

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).

OTHER

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