Creatinine Clearance as a Predictor of Successful Withdrawl of Continuous Renal Replacement Therapy in Intensive Care (STOP EERc)

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.

Study Overview

• Status: Completed
• Conditions: Creatinine Clearance; Dialysis Withdrawal
• Intervention / Treatment: Biological: Blood and urine samples

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients in intensive care

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
creatinine clearance over 2 hours	Through study completion, an average of 2 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NGUYEN 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No