Status:
RECRUITING
Albumin To Enhance Recovery After Acute Kidney Injury
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
The Kidney Foundation of Canada
Conditions:
Acute Kidney Injury
Renal Replacement Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Background: Severe Acute Kidney Injury that necessitates renal replacement therapy (AKI-RRT) is a frequent complication of critical illness and portends severe outcomes: high morbidity, an approximate...
Eligibility Criteria
Inclusion
- 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
- 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:
- Admitted with traumatic brain injury
- Increased intra-cranial pressure in those with intra-cranial pressure monitoring
- Prior history of anaphylaxis to intravenous albumin
- 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
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2025
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT04705896
Start Date
November 2 2023
End Date
October 23 2025
Last Update
May 1 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
The Governors of the University of Calgary
Calgary, Alberta, Canada
2
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, Canada
3
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
4
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada