Albumin To Enhance Recovery After Acute Kidney Injury

NCT04705896 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Hospital Research Institute

Phase

Phase 4

Started

2023-11-02

Last updated

2025-05-01

Condition(s) studied

Acute Kidney InjuryRenal Replacement TherapyHypotensionCritical Illness

Investigational drug(s) / intervention(s)

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

20-25% Albumin fluid (100 mL): 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).

0.9% Normal Saline (100 mL): 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).

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Organ-support-free days (OSFD) — 28 days following randomization
Organ support-free days are defined as days that are both: 1) vasoactive therapy-free; AND 2) mechanical ventilation-free (including NIMV). For patients who die within 28 days following randomization, organ support-free days are counted as -1. An OSFD will be defined as the receipt of \< 2 hours of any vasoactive therapy provided by continuous infusion AND the receipt of \< 2 hours of either invasive or non-invasive mechanical ventilation, within a 24-hour period.

Trial sites (16)

Facility	City	Region	Status
The Governors of the University of Calgary	Calgary	Alberta	Not Yet Recruiting
University of Manitoba - Health Sciences Centre	Winnipeg	Manitoba	Not Yet Recruiting
Nova Scotia Health Authority	Halifax	Nova Scotia	Not Yet Recruiting
Hamilton Health Sciences Corporation	Hamilton	Ontario	Recruiting
Kingston General Hospital	Kingston	Ontario	Recruiting
Sunnybrook Health Sciences Centre	North York	Ontario	Recruiting
The Ottawa Hospital	Ottawa	Ontario	Recruiting
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting
Scarborough Health Network	Scarborough Village	Ontario	Not Yet Recruiting
Niagara Health System	St. Catharines	Ontario	Recruiting
St. Michael's Hospital	Toronto	Ontario	Not Yet Recruiting
Sinai Health System	Toronto	Ontario	Recruiting
Lakeridge Health	Whitby	Ontario	Not Yet Recruiting
Centre Integre de Sante et de Services Sociaux de Laval	Laval	Quebec	Recruiting
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Recruiting
University of Saskatchewan	Saskatoon	Saskatchewan	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04705896 on ClinicalTrials.gov ↗ ← All trials in Canada