Albumin To Enhance Recovery After Acute Kidney Injury

Recruiting now · Phase 4

Conditions studied: Acute Kidney Injury, Renal Replacement Therapy, Hypotension, Critical Illness

In brief

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.

Key facts

Study ID

NCT04705896

Run by

Ottawa Hospital Research Institute

People needed

856

Starts

2023-11-02

Expected to finish

2025-10-23

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years old;
• Admission to a critical care unit/intensive care unit (ICU) for > 24 hours;
• Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));
• Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT during their ICU admission;

You may not qualify if…

• Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;
• Known pre-hospitalization end-stage kidney disease;
• Kidney transplant within the past 365 days;
• Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;
• Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterial peritonitis or hepatorenal syndrome;
• Acute peritoneal dialysis used as the initial RRT modality;
• Contraindications to albumin:
• Admitted with traumatic brain injury
• Increased intra-cranial pressure in those with intra-cranial pressure monitoring
• Prior history of anaphylaxis to intravenous albumin
• Contraindication or known objection to albumin/blood product transfusions
• Already received 2 or more RRT sessions during ICU admission.
• Limitations of medical therapy precluding RRT/mechanical ventilation/vasoactive medications or plan to transition to palliation

Where it is running

• Niagara Health System — St. Catharines, Ontario, Canada (enrolling)
• Kingston General Hospital — Kingston, Ontario, Canada (enrolling)
• Sinai Health System — Toronto, Ontario, Canada (enrolling)
• Sunnybrook Health Sciences Centre — North York, Ontario, Canada (enrolling)
• Centre Integre de Sante et de Services Sociaux de Laval — Laval, Quebec, Canada (enrolling)
• Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (enrolling)
• University of Saskatchewan — Saskatoon, Saskatchewan, Canada
• University of Manitoba - Health Sciences Centre — Winnipeg, Manitoba, Canada
• Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
• Scarborough Health Network — Scarborough Village, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Lakeridge Health — Whitby, Ontario, Canada
• The Governors of the University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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