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

NCT05473143 | Active Not Recruiting DMC

• 1 other identifier: MP-02-2023-10829
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury; Kidney Replacement; Critical Illness

Keywords

Fluid balance management; Ultrafiltration

Outcome Measures

Primary Outcomes (1)

• Cumulative fluid balance

  The difference between quantifiable fluid intake and output

  From randomization to the end of day 5

Secondary Outcomes (18)

• Feasibility: Ability to successfully enroll

  During screening and enrolment

• Feasibility: Protocol adherence

  From randomization to the end of day 5

• Feasibility: Ability to achieve follow-up

  From randomization through day 90.

• Clinical: Death

  From randomization through day 90.

• Clinical: Vasoactive therapy-free days

  From randomization through day 28.

Study Arms (2)

Protocolized fluid removal

EXPERIMENTAL

Other: Protocol-based fluid management

Usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Protocol-based fluid management OTHER

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.

Protocolized fluid removal

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admitted to the ICU
• AKI during current hospitalization defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(1) as any of the following: Increase in serum creatinine by 27 µmol/L or more within any 48-hour window, or an increase in serum creatinine to 1.5 times baseline or more within the last 7 days, or a urine output less than 0.5 mL/kg/h for 6 hours.
• Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours

You may not qualify if:

• Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating physician
• Probable discharge from the ICU within the next 48 hours according to treating physician
• Severe burn injury (\>10% of body surface area)
• Severe abnormality in serum sodium (\>155 or \<120 mmol/L)
• Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours
• The clinical care team believes that the proposed intervention is inappropriate.

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X0A9, Canada

Location

Related Publications (1)

• Shen A, Bouchard J, Neyra JA, Lamontagne F, Cote JM, Clark EG, da Costa BR, Gallagher M, Adhikari NKJ, Silver SA, Suri RS, Ostermann M, Neto AS, Bellomo R, Bagshaw SM, Wald R, Beaubien-Souligny W. Proactive Prescription-Based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy (Probe-Fluid): A Pilot Clinical Trial Protocol. Can J Kidney Health Dis. 2025 Dec 9;12:20543581251391877. doi: 10.1177/20543581251391877. eCollection 2025.

  PMID: 41393271 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Beaubien-Souligny, MD PhD

  CHUM

  STUDY CHAIR

• Ron Wald, MDCM MPH

  Unity Health Toronto

  STUDY CHAIR

• Sean Bagshaw, MD MSc

  University of Alberta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 25, 2022
• Study Start: April 3, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)