Recruiting

AlbuminAlbumin To Enhance Recovery After Acute Kidney Injury

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04705896

Conditions

Acute Kidney Injury

Renal Replacement Therapy

Hypotension

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

20-25% Albumin fluid (100 mL)

0.9% Normal Saline (100 mL)

Study Details

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 20-25% (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.

Conditions

Acute Kidney Injury

Renal Replacement Therapy

Hypotension

Critical Illness

Study ID

NCT04705896

Start date

Nov 2, 2023

Status verified date

Apr, 2025

Completion date

Oct 23, 2025

Anticipated

Primary completion date

Aug 28, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

856 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 20-25% Albumin fluid

100 mL 20-25% Albumin fluid at the initiation of continuous renal replacement therapy (CRRT), prolonged intermittent renal replacement therapy (PIRRT), or intermittent hemodialysis (IHD) and another 100 mL 20-25% Albumin fluid and halfway through RRT sessions in ICU.

placebo comparator: Normal Saline

100 mL at the initiation of CRRT, SLED or IHD and another 100 mL 0.9% Normal Saline halfway through RRT sessions in ICU.

Interventions

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).

Primary outcome measure

Organ-support-free days (OSFD) [ Time Frame: 28 days following randomization ]

Central Contacts and Locations

Central contacts

Edward G Clark, MD MSc FRCPC

613-737-8899 edclark@toh.ca

Irene Watpool, RN BScN

613-737-8724 iwatpool@ohri.ca

Locations

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Emilie Belley-Côté, MD

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Principal Investigator:

Samuel A Silver, MD MSc FRCPC

Sunnybrook Health Sciences Centre

Recruiting

North York, Ontario, Canada, M4N 3M5

Principal Investigator:

Neill Adhikari, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Irene Watpool, RN BScN

613-737-8724 iwatpool@ohri.ca

Heather Langlois, BSc

613-737-8899 hlanglois@ohri.ca

Principal Investigator:

Edward G Clark, MD MSc FRCPC

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Principal Investigator:

Rebecca Mathew, MD FRCPC

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S0A9

Principal Investigator:

Jennifer Tsang, MD, PhD

Sinai Health System

Recruiting

Toronto, Ontario, Canada, M5G1X5

Principal Investigator:

Sangeeta Mehta, MD

Centre Integre de Sante et de Services Sociaux de Laval

Recruiting

Laval, Quebec, Canada, H7M3L9

Principal Investigator:

Marios Roussos, MD

Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada

Principal Investigator:

François Lamontagne, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

Albumin
Normal Saline
Dialysis
Intensive Care Unit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-05-01.