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.
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.
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.
- Conditions
- Dialysis Withdrawal, Creatinine Clearance
- 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.
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.
- First posted5 May 2020
- Study start1 Oct 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis WithdrawalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatinine Clearance as a Predictor of Successful Withdrawl of Continuous Renal Replacement Therapy in Intensive Care
- ClinicalTrials.gov ID
- NCT04375358
- Acronym / sponsor ID
- STOP EERc / NGUYEN 2018
- Conditions
- Dialysis Withdrawal, Creatinine Clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Inpatients in intensive care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine samplesTo measure the clearance of creatinine, urea, potassium, magnesium, sodium, chlorine... | Biological | – |
Primary outcome
creatinine clearance over 2 hours
Time frame: Through study completion, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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Kidney Failure, Chronic Therapy; Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.