Albumin To Enhance Recovery After Acute Kidney Injury
Acute Kidney Injury | Critical Illness | Renal Replacement Therapy | HypotensionStudy 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
Hamilton Health Sciences Corporation
Hamilton Health Sciences CorporationHamilton, Ontario
Canada
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University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
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Rebecca Mathew, MD FRCPC
Sinai Health System
Sinai Health SystemToronto, Ontario
Canada
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University of Saskatchewan
University of SaskatchewanSaskatoon, Saskatchewan
Canada
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Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
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The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Ron Wald, MDCM MPH
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de SherbrookeSherbrooke, Quebec
Canada
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The Governors of the University of Calgary
The Governors of the University of CalgaryCalgary, Alberta
Canada
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Kingston General Hospital
Kingston General HospitalKingston, Ontario
Canada
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Samuel A Silver, MD MSc FRCPC
Scarborough Health Network
Scarborough Health NetworkScarborough, Ontario
Canada
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Lakeridge Health
Lakeridge HealthWhitby, Ontario
Canada
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Shannon Fernando, MD
University of Manitoba - Health Sciences Centre
University of Manitoba - Health Sciences CentreWinnipeg, Manitoba
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreNorth York, Ontario
Canada
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Niagara Health System
Niagara Health SystemSt. Catharines, Ontario
Canada
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Jennifer Tsang, MD, PhD
Centre Integre de Sante et de Services Sociaux de Laval
Centre Integre de Sante et de Services Sociaux de LavalLaval, Quebec
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT04705896