Albumin To Enhance Recovery After Acute Kidney Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
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 groupsSponsors 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