NCT06214390

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

Weaning of Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury: Predictive Performance of Urinary Parameters
University Hospital, Montpellier·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Acute Kidney Injury
Drug/Device/Intervention
Single strategy
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
University Hospital, Montpellier
Location
Clermont-Ferrand,Montpellier, France
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2024
End date
Dec 01, 2025
Enrollment
600 participants
Primary outcome

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

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.

ICD-10 classifications
Injury of kidneyAcute renal failureAcute renal failure, unspecifiedOther acute renal failureAcute renal failure with tubular necrosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06214390
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06214390 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Montpellier and is currently Not yet recruiting. The study focuses on Acute Kidney Injury. Target enrollment is 600 participants.

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