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

NCT05473143 · tracked via the Priya Life Science Canada tracker

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Phase

Not applicable

Started

2023-04-03

Last updated

2026-03-19

Condition(s) studied

Acute Kidney InjuryKidney ReplacementCritical Illness

Investigational drug(s) / intervention(s)

Protocol-based fluid managementUsual care

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.

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 years 2. Admitted to the ICU 3. 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. 4. Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours Exclusion Criteria: 1. 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 2. Probable discharge from the ICU within the next 48 hours according to treating physician 3. Severe burn injury (\>10% of body surface area) 4. Severe abnormality in serum sodium (\>155 or \<120 mmol/L) 5. Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours 6. The clinical care team believes that the proposed intervention is inappropriate.

Primary outcome measure(s)

Cumulative fluid balance — From randomization to the end of day 5
The difference between quantifiable fluid intake and output

Trial sites (1)

Facility	City	Region	Status
Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05473143 on ClinicalTrials.gov ↗ ← All trials in Canada