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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Niagara Health System
  St. Catharines, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Edward G Clark, MD MSc FRCPC — Ottawa Hospital Research Institute
• Study coordinator: Edward G Clark, MD MSc FRCPC
• Email: edclark@toh.ca
• Phone: 613-737-8899

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This project will collect and compare data on adults in ICUs across Latin America who need dialysis for severe acute kidney injury to see how they are treated and what outcomes they have.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.