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.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
Hamilton Health Sciences Corporation
Hamilton Health Sciences CorporationHamilton, Ontario
Canada
Contactez l'équipe d'étude
University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
Contactez l'équipe d'étude
Rebecca Mathew, MD FRCPC
Sinai Health System
Sinai Health SystemToronto, Ontario
Canada
Contactez l'équipe d'étude
University of Saskatchewan
University of SaskatchewanSaskatoon, Saskatchewan
Canada
Contactez l'équipe d'étude
Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
Contactez l'équipe d'étude
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
Contactez l'équipe d'étude
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
Contactez l'équipe d'étude
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
Contactez l'équipe d'étude
The Governors of the University of Calgary
The Governors of the University of CalgaryCalgary, Alberta
Canada
Contactez l'équipe d'étude
Kingston General Hospital
Kingston General HospitalKingston, Ontario
Canada
Contactez l'équipe d'étude
Samuel A Silver, MD MSc FRCPC
Scarborough Health Network
Scarborough Health NetworkScarborough, Ontario
Canada
Contactez l'équipe d'étude
Lakeridge Health
Lakeridge HealthWhitby, Ontario
Canada
Contactez l'équipe d'étude
Shannon Fernando, MD
University of Manitoba - Health Sciences Centre
University of Manitoba - Health Sciences CentreWinnipeg, Manitoba
Canada
Contactez l'équipe d'étude
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreNorth York, Ontario
Canada
Contactez l'équipe d'étude
Niagara Health System
Niagara Health SystemSt. Catharines, Ontario
Canada
Contactez l'équipe d'étude
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
Contactez l'équipe d'étude
- Étude parrainée par
- Ottawa Hospital Research Institute
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04705896