Albumin To Enhance Recovery After Acute Kidney Injury

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

Interventions

BIOLOGICAL

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).

OTHER

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).

Sponsors & Collaborators

• The Physicians' Services Incorporated Foundation

  collaborator OTHER

• The Kidney Foundation of Canada

  collaborator OTHER

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

  collaborator UNKNOWN

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Blood Services

  collaborator OTHER

• Héma-Québec

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Edward G Clark, MD MSc FRCPC · Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-02

Primary Completion

2025-08-28

Completion

2025-10-23

Countries

• Canada

Study Locations