Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy

NCT05473143 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-19

No results posted yet for this study

Summary

A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.

Conditions

Interventions

OTHER

Protocol-based fluid management

Fluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components. Fluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components. The first component of this prescription will be to define the 24h-fluid balance target either aiming for a negative fluid balance of 2 to 3% body weight (1.4-2.1 liters in a 70 Kg participant) (Option 1) or by aiming to avoid fluid accumulation by targeting a neutral fluid balance within 0.5% of body weight variation (-350 to +350 mL in a 70 Kg participant) (Option 2). The second component is to pre-specify a prescription for fluid removal using KRT. The third component is to prompt a daily re-evaluation of fluid intake by the attending care team.

OTHER

Usual care

The net fluid removal and the rate of net fluid removal will not be protocolized and will be prescribed and adjusted according to the attending care team without any specific guidance. The use of the documents provided for the intervention group will not be permitted in the control arm.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • William Beaubien-Souligny, MD PhD · CHUM

  • Ron Wald, MDCM MPH · Unity Health Toronto

  • Sean Bagshaw, MD MSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2026-01-01
Completion
2026-09-01

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473143 on ClinicalTrials.gov