Urinary Parameters to Predict Weaning of Renal Replacement Therapy in the Critically Ill

NCT06214390 | Unknown DMC

• 1 other identifier: RECHMPL21_0530
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

Data on the optimal period for RRT weaning in critically ill patient are scarce. The current practice for RRT weaning is based on urine output, the threshold of which is debatable. Two recent observational studies have shown that an increase in urinary creatinine or urea concentrations is a better predictive marker of RRT weaning than urine output. An unjustified delay in RRT weaning leads to numerous complications such as catheter-related infections, delay of the patient's functional recovery, severe ionic disorder, bleeding, and induced hemodynamic instability. It also induces an increase workload for careers and in cost without any additional benefit for the patient. Conversely, too early weaning inevitably limits the prevention on fluid accumulation that is independently associated with an increased risk of mortality and inevitably leads to resumption of RRT requiring reinsertion of dialysis catheter resulting in potential complications. A multicentre randomized controlled trial will be then necessary and only able to identify the optimal RRT weaning strategy. The main objective is to compare two RRT weaning strategies on RRT duration in critically ill patients with acute kidney injury: a strategy based on combined criteria (urine output + urinary parameters) as compared to a single strategy based only on urine output. The study protocol will be an open-label, two parallel group, multicenter, randomized, controlled clinical trial, in which enrolled ICU adult patients will have RRT weaning based either on urine output alone (single strategy) or on urine output and urinary parameters (combined strategy). When the urine output is greater than 500ml/24h, the enrollment must be performed within 24hours in 2 groups:. " Single strategy ": In the single strategy, RRT weaning will be achieved when urine output exceeds 500ml/24h without diuretics or 2000ml/24h with diuretics use. " Combined strategy": In the combined strategy, when urine output exceeds 500ml/day with or without diuretic use, RRT will be stopped during 48h to assess urinary indices (urinary creatinine and urea). Soon as urinary indices are higher than thresholds values (urinary creatinine \> 5.2mmol/day and urinary urea \> 1.35mmol/kg/day, RRT will be weaned. If they are lower, a RRT session will be perform after which the weaning process will be resume. The primary endpoint is the number of RRT-free days at D30 with at least 7 consecutive days alive and without RRT.

Conditions

Acute Kidney Injury

Keywords

Renal Replacement Therapy; Urine Ouput; Weaning; Critical care; urinary biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of RRT-free days at D30 with at least 7 consecutive days alive and without RRT

  Days without RRT

  Day30

Secondary Outcomes (26)

• Number of RRT weaned days at Day90

  Day90

• Number of RRT sessions in ICU and at Day90

  in ICU and at Day90

• Renal recovery at Day30

  Day30

• Renal recovery at Day90

  Day90

• Serum Creatinine and urea at ICU discharge

  Day of ICU discharge

Study Arms (2)

Single strategy

ACTIVE COMPARATOR

A single strategy based only on urine output

Procedure: Single strategy

Combined strategy

EXPERIMENTAL

A strategy based on combined criteria (urine output + urinary parameters)

Procedure: Combined strategy

Interventions

Single strategy PROCEDURE

In the single strategy, RRT weaning will be achieved when urine output exceeds 500ml/24h without diuretics or 2000ml/24h with diuretics use

Single strategy

Combined strategy PROCEDURE

In the combined strategy, when urine output exceeds 500ml/day with or without diuretic use, RRT will be stopped during 48h to assess urinary indices (urinary creatinine and urea). Soon as urinary indices are higher than thresholds values (urinary creatinine \> 5.2mmol/day \[5\] and 3) urinary urea \> 1.35mmol/kg/day (using the patient's body weight at ICU admission) \[6\], RRT will be weaned. If they are lower, a RRT session will be perform after which the weaning process will be resume.

Combined strategy

Eligibility Criteria

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

You may qualify if:

• Adults (18 years of age or older)
• Admitted to the ICU
• Receiving or having received invasive mechanical ventilation and/or catecholamine infusion (epinephrine or norepinephrine or dobutamine) at least 48h
• With acute kidney injury, at KDIGO 3 (See Appendix 1) stage and associated with oliguria at least \< 200ml/ 24h before RRT initiation
• Treated with intermittent or continuous renal replacement therapy
• Resumption of urine output \> 300ml/24h with or without diuretic use

You may not qualify if:

• Preexisting Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30ml/min
• AKI caused by vascular occlusion, glomerulonephritis, vasculitis, post-renal obstruction, thrombotic microangiopathy, tumor lysis syndrome
• RRT for another cause than AKI (eg: drug intoxication,...)
• Decision to forgo life-sustaining treatment including RRT
• Cirrhosis with Child-Pugh score of C or hepatorenal syndrome
• Kidney transplantation
• Patient already enrolled in the study
• Participation in another clinical trial assessing the impact or duration of RRT
• Pregnancy in progress or planned during the study period or breastfeeding women
• Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique) : Adult protected by law or patient under guardianship or curatorship
• Subjects not covered by public health insurance

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Clermont-Ferrand Hospital University

Clermont-Ferrand, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Kada KLOUCHE

CONTACT

0467338441; k-klouche@chu-montpellier.fr

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: December 21, 2023
• First Posted: January 19, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)