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Dialysis WithdrawalSTOP EERcNCT04375358

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

An observational study of Dialysis Withdrawal and Creatinine Clearance, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dialysis Withdrawal, Creatinine Clearance
What is being tested?
Blood and urine samples
How many people
64 participants
Where
1 siteFrance
Study dates
1 Oct 2018to 30 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Inpatients in intensive care

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Decision to limit or stop therapy
  • Isolated hyperkalemia
  • Refusal of patient participation

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Dijon Bourgogne

    Dijon, 21000

Other trials in France

About this study

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.

Read more

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.

Being tested
Blood and urine samples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood and urine samplesBiological

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. creatinine clearance over 2 hours

    Measured: Through study completion, an average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start1 Oct 2018
  3. Primary completion30 Mar 2021
  4. Study completion30 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04375358
Sponsor's protocol ID
NGUYEN 2018
Acronym
STOP EERc
Status last verified
May 2021
First submitted
27 Apr 2020
Last updated
2 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dialysis Withdrawal and Creatinine Clearance, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

creatinine clearance over 2 hours (time frame: Through study completion, an average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.

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