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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04375358
Other study ID # NGUYEN 2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date March 30, 2021

Study information

Verified date May 2021
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood and urine samples
To measure the clearance of creatinine, urea, potassium, magnesium, sodium, chlorine...

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary creatinine clearance over 2 hours Through study completion, an average of 2 hours
See also
  Status Clinical Trial Phase
Unknown status NCT00396396 - Role of Acetylcysteine in Creatinine Clearance N/A