Comparing fluid management strategies in critically ill patients on kidney replacement therapy

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

This study tests a new way of managing fluids in critically ill patients on kidney treatment to see if it helps them better than the usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Academic / other)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT05473143 on ClinicalTrials.gov

What this trial studies

This pilot randomized clinical trial evaluates a protocol-based fluid management strategy against usual care for critically ill patients undergoing kidney replacement therapy due to acute kidney injury. The study aims to achieve a neutral or negative daily fluid balance by preventing and treating fluid accumulation, which is crucial for improving patient outcomes. The protocol allows for standardized fluid removal while enabling the care team to adjust treatment based on clinical evaluations. The primary goal is to assess the difference in cumulative fluid balance over five days from randomization.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are admitted to the ICU with acute kidney injury and are planned to initiate kidney replacement therapy.

Not a fit: Patients who are transitioning to comfort care or are expected to be discharged from the ICU within 48 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved fluid management and better outcomes for critically ill patients with acute kidney injury.

How similar studies have performed: While the specific protocol-based approach may be novel, there is existing literature suggesting that improved fluid management can positively impact outcomes in similar patient populations.

Eligibility criteria

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.

Where this trial is running

Montréal, Quebec

• Centre Hospitalier de l'Université de Montréal — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: William Beaubien-Souligny, MD PhD

Conditions Acute Kidney Injury; Kidney Replacement; Critical Illness; Fluid balance management; Ultrafiltration