Using albumin to improve recovery in critically ill patients with acute kidney injury

Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial

This study is testing whether giving critically ill patients with acute kidney injury a special type of albumin instead of regular saline can help them recover better and need less kidney treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 856 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 16 sites (Calgary, Alberta and 15 other locations)
• Trial ID: NCT04705896 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of intravenous hyperoncotic albumin compared to normal saline in critically ill patients experiencing acute kidney injury who require renal replacement therapy. The study will randomize participants to receive either albumin or saline during their treatment sessions, with the primary goal of increasing organ support-free days and renal replacement therapy-free days within 28 days. By addressing the challenges of hypotension and organ ischemia during renal replacement therapy, the trial seeks to provide definitive evidence on the efficacy of albumin in this patient population.

Who should consider this trial

Good fit: Ideal candidates include critically ill adults aged 18 and older who are admitted to an intensive care unit and require renal replacement therapy for acute kidney injury.

Not a fit: Patients with end-stage kidney disease or those requiring renal replacement therapy for reasons other than acute kidney injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved recovery outcomes and reduced reliance on renal replacement therapy for critically ill patients with acute kidney injury.

How similar studies have performed: While the use of albumin in this context is common, definitive evidence from similar studies is limited, making this trial a potentially novel investigation.

Eligibility criteria

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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:

  1. Admitted with traumatic brain injury
  2. Increased intra-cranial pressure in those with intra-cranial pressure monitoring
  3. Prior history of anaphylaxis to intravenous albumin
  4. 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 this trial is running

Calgary, Alberta and 15 other locations

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

Study contacts

• Principal investigator: Edward G Clark, MD MSc FRCPC — Ottawa Hospital Research Institute
• Study coordinator: Edward G Clark, MD MSc FRCPC

Conditions Acute Kidney Injury; Renal Replacement Therapy; Hypotension; Critical Illness; Albumin; Normal Saline; Dialysis; Intensive Care Unit