Albumin To Enhance Recovery After Acute Kidney Injury
Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial
Ottawa Hospital Research Institute
856 participants
Nov 2, 2023
INTERVENTIONAL
Conditions
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 20-25% (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
Inclusion Criteria4
- 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 Criteria13
- 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
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Interventions
Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).
Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomization then every 12 hours while continuing on CRRT).
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT04705896