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Albumin To Enhance Recovery After Acute Kidney Injury

RecruitingPhase 4Ages 18 Years - anyAllOttawa Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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
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What it tests

  • 20-25% Albumin fluid (100 mL)
  • 0.9% Normal Saline (100 mL)
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Where

16 sites
The Governors of the University of Calgary
Calgary, Canada
University of Manitoba - Health Sciences Centre
Winnipeg, Canada
Nova Scotia Health Authority
Halifax, Canada
Hamilton Health Sciences Corporation
Hamilton, Canada
Kingston General Hospital
Kingston, Canada
Sunnybrook Health Sciences Centre
North York, Canada
The Ottawa Hospital
Ottawa, Canada
University of Ottawa Heart Institute
Ottawa, Canada

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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