Albumin To Enhance Recovery After Acute Kidney Injury

NCT ID: NCT04705896

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 856 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2025-10-23

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.

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 approximately 50% risk of in-hospital death, and increased healthcare resource utilization. Although life-saving when needed, RRT itself may contribute to the poor outcomes associated with AKI-RRT. Since RRT treatments frequently cause hypotension, repeated episodes of kidney and other organ ischemia may occur during RRT. Hypotension during RRT is often triggered by fluid removal. At the same time, there is some evidence that more aggressive ultrafiltration could be beneficial in AKI-RRT.

Albumin is a protein that is the primary contributor to the colloid oncotic pressure maintaining the effective circulating volume (ECV) during RRT. Critically ill patients with AKI-RRT are nearly always hypoalbuminemic. Despite its high cost and limited evidence to support the practice, intravenous hyperoncotic albumin is commonly administered to patients with AKI-RRT in an effort to boost the colloid oncotic pressure and maintain the blood pressure while simultaneously facilitating fluid removal

Objective:

This proposed trial is intended to provide definitive evidence as to the efficacy of a frequently used and expensive intervention to promote hemodynamic stability and augment ultrafiltration during RRT in critically ill patients

Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of five Canadian tertiary care hospitals with plans to expand to include other centres across Canada and internationally.

Study Population: 856 patients admitted to the Intensive Care Unit (ICU) with AKI requiring treatment with RRT .

Intervention: Participants will be randomized 1:1 to receive either albumin (20-25%) boluses or normal saline placebo boluses at the start and halfway through RRT sessions in ICU, during their RRT treatments to a maximum of 14 days.

Conditions

Acute Kidney Injury; Renal Replacement Therapy; Hypotension; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

20-25% Albumin fluid (100 mL)

Intervention Type: BIOLOGICAL

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).

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.

Group Type: PLACEBO_COMPARATOR

0.9% Normal Saline (100 mL)

Intervention Type: OTHER

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).

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).

Intervention Type: BIOLOGICAL

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

The Kidney Foundation of Canada

OTHER

Sponsor Role: collaborator

The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Blood Services

OTHER

Sponsor Role: collaborator

Héma-Québec

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Edward Clark

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward G Clark, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Governors of the University of Calgary

Calgary, Alberta, Canada

Site Status: NOT_YET_RECRUITING

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status: NOT_YET_RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status: NOT_YET_RECRUITING

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Site Status: RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

Site Status: RECRUITING

Sunnybrook Health Sciences Centre

North York, Ontario, Canada

Site Status: RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Scarborough Health Network

Scarborough Village, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Niagara Health System

St. Catharines, Ontario, Canada

Site Status: RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Sinai Health System

Toronto, Ontario, Canada

Site Status: RECRUITING

Lakeridge Health

Whitby, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Centre Integre de Sante et de Services Sociaux de Laval

Laval, Quebec, Canada

Site Status: RECRUITING

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

Sherbrooke, Quebec, Canada

Site Status: RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Edward G Clark, MD MSc FRCPC

Role: CONTACT

edclark@toh.ca

613-737-8899 ext. 82569

Irene Watpool, RN BScN

Role: CONTACT

iwatpool@ohri.ca

613-737-8724

Facility Contacts

Samuel A Silver, MD MSc FRCPC

Role: primary

Irene Watpool, RN BScN

Role: primary

iwatpool@ohri.ca

613-737-8724

Heather Langlois, BSc

Role: backup

hlanglois@ohri.ca

613-737-8899 ext. 72998

Rebecca Mathew, MD FRCPC

Role: primary

Jennifer Tsang, MD, PhD

Role: primary

Ron Wald, MDCM MPH

Role: primary

Shannon Fernando, MD

Role: primary

References

Ullrich EK, Callum J, Clark EG. Use of Intravenous Albumin in Nephrology Practice Should Be Guideline-Based. J Am Soc Nephrol. 2025 Apr 30;36(7):1446-1449. doi: 10.1681/ASN.0000000750. No abstract available.

Reference Type: DERIVED

PMID: 40305120 (View on PubMed)

Other Identifiers

CRF1819

Identifier Type: -

Identifier Source: org_study_id