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Albumin To Enhance Recovery After Acute Kidney Injury

Acute Kidney Injury | Critical Illness | Renal Replacement Therapy | Hypotension

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.

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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 Corporation
Hamilton, Ontario
Canada

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University of Ottawa Heart Institute
University of Ottawa Heart Institute
Ottawa, Ontario
Canada

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Primary Contact

Rebecca Mathew, MD FRCPC

Sinai Health System
Sinai Health System
Toronto, Ontario
Canada

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University of Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan
Canada

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Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

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The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

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Backup Contact

Heather Langlois, BSc

[email protected]
613-737-8899
Primary Contact

Irene Watpool, RN BScN

[email protected]
613-737-8724
St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

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Primary Contact

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 Sherbrooke
Sherbrooke, Quebec
Canada

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The Governors of the University of Calgary
The Governors of the University of Calgary
Calgary, Alberta
Canada

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Kingston General Hospital
Kingston General Hospital
Kingston, Ontario
Canada

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Primary Contact

Samuel A Silver, MD MSc FRCPC

Scarborough Health Network
Scarborough Health Network
Scarborough, Ontario
Canada

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Lakeridge Health
Lakeridge Health
Whitby, Ontario
Canada

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Primary Contact

Shannon Fernando, MD

University of Manitoba - Health Sciences Centre
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba
Canada

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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
North York, Ontario
Canada

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

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Primary Contact

Jennifer Tsang, MD, PhD

Centre Integre de Sante et de Services Sociaux de Laval
Centre Integre de Sante et de Services Sociaux de Laval
Laval, Quebec
Canada

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Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT04705896