NCT04375358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

April 27, 2020

Last Update Submit

May 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • creatinine clearance over 2 hours

    Through study completion, an average of 2 hours

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients in intensive care

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 5, 2020

Study Start

October 1, 2018

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations