NCT04705896

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. 1.An increase in organ support-free days (primary outcome) at 28 days following randomization; and
  2. 2.An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
856

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
2.8 years until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

January 7, 2021

Last Update Submit

April 30, 2025

Conditions

Acute Kidney InjuryRenal Replacement TherapyHypotensionCritical Illness

Keywords

AlbuminNormal SalineDialysisIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Organ-support-free days (OSFD)

    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.

    28 days following randomization

Secondary Outcomes (21)

  • RRT-free days through day 28

    Through day 28

  • Vasoactive therapy free days

    Through day 28

  • Mechanical ventilation-free days

    Though day 28.

  • ICU free days

    Through 28 days

  • Number of participants with death in ICU

    Through 28 days

  • +16 more secondary outcomes

Study Arms (2)

20-25% Albumin fluid

ACTIVE COMPARATOR

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.

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

Normal Saline

PLACEBO COMPARATOR

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

Other: 0.9% Normal Saline (100 mL)

Interventions

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

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

Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

The Governors of the University of Calgary

Calgary, Alberta, Canada

NOT YET RECRUITING

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

NOT YET RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

NOT YET RECRUITING

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

RECRUITING

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

North York, Ontario, M4N 3M5, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Scarborough Health Network

Scarborough Village, Ontario, Canada

NOT YET RECRUITING

Niagara Health System

St. Catharines, Ontario, L2S0A9, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Sinai Health System

Toronto, Ontario, M5G1X5, Canada

RECRUITING

Lakeridge Health

Whitby, Ontario, L1N 6K9, Canada

NOT YET RECRUITING

Centre Integre de Sante et de Services Sociaux de Laval

Laval, Quebec, H7M3L9, Canada

RECRUITING

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

Sherbrooke, Quebec, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 40305120DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryHypotensionCritical Illness

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Edward G Clark, MD MSc FRCPC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward G Clark, MD MSc FRCPC

CONTACT

613-737-8899edclark@toh.ca

Irene Watpool, RN BScN

CONTACT

613-737-8724iwatpool@ohri.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blood Banks at participating sites prepare intravenous hyperoncotic albumin and normal saline (control) in identical infusion mini-bags. Opaque bags and intravenous tubing covers will be used to maintain blinding as much as possible. The packaging for normal saline and 25% albumin will be identical (mini-bags) and be covered. The intravenous tubing will have an opaque sleeve to mask any colour discrepancy in the 2 product
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with two parallel arms 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

November 2, 2023

Primary Completion

August 28, 2025

Study Completion

October 23, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data collected during the ALTER-AKI trial will be shared with researchers who provide a detailed and methodologically sound proposal, with specific aims. Data sharing will be for the purposes of medical research, with specific data elements provided to answer the research questions in the proposal, and under the auspices of the consent under which the data were originally gathered

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data availability will commence 6 months after the publication of the primary and secondary analyses, with no anticipated end date
Access Criteria
Qualified researchers will need to sign a data sharing and access agreement and will need to confirm that data will only be used for the agreed upon purpose for which data access was granted. The decision to grant access will be made by the trial co-principal investigators, with involvement of the trial steering committee as needed. Proposals to access ALTER-AKI data should be directed to the trial principal investigator via email: Edward Clark--edclark@toh.ca. Costs of preparing and providing partial datasets will be charged to requesting investigators

Locations

CA(16)