Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04705896

Albumin To Enhance Recovery After Acute Kidney Injury

Led by Ottawa Hospital Research Institute · Updated on 2025-05-01

856

Participants Needed

16

Research Sites

103 weeks

Total Duration

On this page

Sponsors

O

Ottawa Hospital Research Institute

Lead Sponsor

T

The Physicians' Services Incorporated Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Albumin To Enhance Recovery After Acute Kidney Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Admitted to an intensive care or critical care unit for more than 24 hours
  • Receiving vasoactive therapy and/or mechanical ventilation (including non-invasive ventilation)
  • Immediate start of renal replacement therapy for acute kidney injury planned or additional RRT sessions planned after prior RRT in ICU
Not Eligible

You will not qualify if you...

  • Starting renal replacement therapy for reasons other than acute kidney injury (e.g., drug overdose, hypothermia)
  • Known end-stage kidney disease before hospital admission
  • Kidney transplant within the last 365 days
  • Presence or suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy, or acute interstitial nephritis
  • Advanced liver disease (Child Pugh class C), spontaneous bacterial peritonitis, or hepatorenal syndrome
  • Use of acute peritoneal dialysis as first RRT method
  • Contraindications to albumin, including traumatic brain injury, increased intracranial pressure, history of anaphylaxis to albumin, or refusal of albumin/blood transfusions
  • Already had two or more RRT sessions during this ICU stay
  • Medical limitations preventing RRT, mechanical ventilation, vasoactive medications, or plans for palliative care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

The Governors of the University of Calgary

Calgary, Alberta, Canada

Not Yet Recruiting

2

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

Not Yet Recruiting

3

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Not Yet Recruiting

4

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Actively Recruiting

5

Kingston General Hospital

Kingston, Ontario, Canada, K7L 2V7

Actively Recruiting

6

Sunnybrook Health Sciences Centre

North York, Ontario, Canada, M4N 3M5

Actively Recruiting

7

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

8

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

9

Scarborough Health Network

Scarborough Village, Ontario, Canada

Not Yet Recruiting

10

Niagara Health System

St. Catharines, Ontario, Canada, L2S0A9

Actively Recruiting

11

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

12

Sinai Health System

Toronto, Ontario, Canada, M5G1X5

Actively Recruiting

13

Lakeridge Health

Whitby, Ontario, Canada, L1N 6K9

Not Yet Recruiting

14

Centre Integre de Sante et de Services Sociaux de Laval

Laval, Quebec, Canada, H7M3L9

Actively Recruiting

15

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

Sherbrooke, Quebec, Canada

Actively Recruiting

16

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Not Yet Recruiting

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Research Team

E

Edward G Clark, MD MSc FRCPC

CONTACT

I

Irene Watpool, RN BScN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Albumin To Enhance Recovery After Acute Kidney Injury | DecenTrialz