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OpenTrials
Completed

NCT Number: NCT04375358

Creatinine Clearance as a Predictor of Successful Withdrawl of Continuous Renal Replacement Therapy in Intensive Care

Acute renal failure is a common complication in patients admitted to intensive care. Due to the increasing incidence of acute renal failure, the use of Continuous Renal Replacement Therapy (CRRT) is on the rise in the intensive care unit. The use of CRRT exposes patients to some complications (bleeding, hemodynamic instability, antibiotic underdosing, malnutrition and infections), justifying the importance of optimizing the quality and reliability of this technique. Renal function is classically assessed by diuresis and creatinine. Creatinine clearance is an indirect measure of glomerular filtration rate. Measuring creatinine clearance is a simple, accessible and relatively inexpensive method. Traditionally, clreatinine clearance has required 24-hour urine collection. However, it has been shown that two-hour urine collection is also an accurate tool.

There is little information and few recommendations as to when to discontinue CRRT. A predictive index for the withdrawal of CRRT would reduce the duration of treatment, reduce complications and costs, and speed up patient rehabilitation.

Various parameters have been described as tools for deciding when to stop dialysis: diuresis before stopping CRRT, urine and blood creatinine, daily urinary urea excretion, and sodium and water balance. Among these factors, urine output and creatinine appear to be promising predictive factors. The measurement of creatinine clearance combines these two factors and can therefore be a good tool for predicting the return of adequate renal function. Retrospective work carried out by Fröhlich et al in 2012 suggested that creatinine clearance measured over 2 hours could be a good marker for successful withdrawal.

The hypothesis of the study is that creatinine clearance measured over 2 hours after stopping CRRT is be predictive of the success of the withdrawal from this type of therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dialysis for AKI with minimum 12 hours of continuous renal replacement therapy (CVVH-CVVHD)
  • Patient in whom dialysis withdrawal is being considered
  • Patients over 18 years of age

Exclusion criteria

  • Pre-existing chronic end-stage renal failure on chronic dialysis
  • Extrarenal purification during hospitalization prior to admission to intensive care unit
  • Inability to assess the primary outcome
  • Kidney Transplantation
  • Pregnant Women
  • Person not affiliated to a national health insurance
  • Decision to limit or stop therapy
  • Isolated hyperkalemia
  • Refusal of patient participation

Treatment and study plan

Blood and urine samples

Biological

To measure the clearance of creatinine, urea, potassium, magnesium, sodium, chlorine...

Primary outcomes

  1. creatinine clearance over 2 hours

    Time frame: Through study completion, an average of 2 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: STOP EERc

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.