Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

856 Participants
are divided into 2 treatment groups

Locations

16
Alberta
The Governors of the University of Calgary Calgary Canada
Manitoba
University of Manitoba - Health Sciences Centre Winnipeg Canada
Nova Scotia
Nova Scotia Health Authority Halifax Canada
Ontario
Hamilton Health Sciences Corporation Hamilton Canada

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor

The Physicians' Services Incorporated Foundation

Collaborator

The Kidney Foundation of Canada

Collaborator

The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Blood Services

Collaborator

Héma-Québec

Collaborator

Source ClinicalTrials.gov