Extracorporeal Membrane Oxygenation ComplicationCREA-ECMONCT03525483
Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance
A study testing Ultrasound for renal resistivity index measurement in people with Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of the study will be to evaluate the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of creatinine, which can be performed routinely in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Ultrasound for renal resistivity index measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2018to Nov 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18
- ECMO VV or VA after 48 hours of installation
- Hemodynamic stability for at least 12 hours
- Person affiliated or benefiting from a social security scheme
- Having expressed an express consent OR patient for whom a relative has given express consent
Who cannot join
- Hemodynamic instability
- Chronic renal failure patients receiving dialysis
- Need for continuous or intermittent extra-renal cleansing
- Patients under the protection of justice
- Person participating in another search including an exclusion period still in progress
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Stéphanie Ruiz, MD, 05 61 32 44 64 ext. 33, ruiz.stephanie@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance: Estimation Formula Versus Measured Clearance of Creatinine
The aim of the study will be to evaluate the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of creatinine, which can be performed routinely in intensive care.
To determine the proportion of patients with ARC under ECMO VV or VA and determine changes in renal vascular resistance index as a function of GFR level in patients with pulsatile cardiac output.
Read the detailed description
Extracorporeal assistance is recommended for patients with a potentially reversible acute risk of life that does not respond to conventional treatments. Hypoxic refractory syndromes, such as acute respiratory distress syndrome, are referred to as veno-venous ECMO (for Extracorporeal Membrane Oxygenation) (ECMO VV), whereas terminal cardiac dysfunctions require veno-arterial ECMO (VA ECMO). recovery of function (cardiotropic intoxication), or in the most severe cases, pending transplantation or long-term assistance.
This is a qualified pilot study, as it is the first one interested in evaluating the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft formula) by relative to the measured clearance of creatinine, a method that can be performed routinely in intensive care, for resuscitation patients under veno-arterial or veno-venous ECMO.
- Being tested
- Ultrasound for renal resistivity index measurement
- Keywords
- ECMO, Acute renal failure
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound for renal resistivity index measurementDiagnostic test
Collection of urine over 3 hours for creatinine clearance measurement, with serum creatinine in parallel with urine collection to calculate measured creatinine clearance and estimate glomerular filtration rate Evaluation of the renal vascular resistance index in Doppler ultrasound by a resuscitator trained in the technique at the time of inclusion.
Collection of demographic, clinical and biological data for inclusion of the patient such as weight, age, sex, arterial lactatemia, arterial pH, volume status, use of diuretics, use of vasopressors, use of nephrotoxic drugs ...
| Study group | Role | What they receive |
|---|---|---|
| Patients with ECMO | Experimental | Patients with circulatory assistance by ECMO Patients are included 48 hours after ECMO VA or VV therapy and after hemodynamic stabilization defined by blood pressure stability and cardiac output for at least 12 hours without significant changes in amine flow.
When stable they will have an Ultrasound for renal resistivity index measurement Receives: Diagnostic Test: Ultrasound for renal resistivity index measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the clearance of creatinine in urine with GFR
Measured clearance of creatinine in urine (collected over 3 hours during haemodynamic stabilization of the patient) that will be compared to the Glomerular Filtration Rate(GFR) (estimated according to the Cockcroft and CKD-EPI formulas).
Measured: 1 hour
Secondary outcomes (3)
Number of patients in ECMO with augmented renal clearance (ARC)
In intensive care, some patients also have an often unrecognized increase in creatinine clearance. This entity named "augmented renal clearance" or ARC is defined by creatinine clearance> 150 mL / min / 1.73 m² for a woman and> 160 mL / min / 1.73 m² for a man. It is causing a decrease in the plasma concentration of certain drugs, especially antibiotics, which can lead to a therapeutic failure.
A poor evaluation of the renal function in the intensive care unit can lead to overdoses or to underdosages of the drugs, by phenomena of hypofiltration or on the contrary of renal hyperfiltration.
Measured: 1 hour
Index of renal vascular resistance
index of renal vascular resistance obtained by Doppler ultrasound by a resuscitator trained in the technique at the time of inclusion.
Measured: 18 months
Differences in the variable GFR between patients with glomerular hypofiltration
Differences in the variable GFR between patients with glomerular hypofiltration, normofiltration and hyperfiltrating patients with ClCr <60 mL / min / 1.73 m², and for normofiltration patients and hyperfiltrate patients it means CrCl> 150 mL / min / 1.73 m² for a woman and CrCl> 160 mL / min / 1.73 m² for a ma).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start19 Jul 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Ruiz, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525483
- Sponsor's protocol ID
- RC31/18/0127
- Other IDs
- 2018-A00907-48
- Acronym
- CREA-ECMO
- Status last verified
- Jul 2018
- First submitted
- 16 Apr 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance: Estimation Formula Versus Measured Clearance of Creatinine
- ClinicalTrials.gov ID
- NCT03525483
- Acronym / sponsor ID
- CREA-ECMO / RC31/18/0127
- Keywords
- ECMO, Acute renal failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 15 May 2018 (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.
The aim of the study will be to evaluate the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of creatinine, which can be performed routinely in intensive care.
To determine the proportion of patients with ARC under ECMO VV or VA and determine changes in renal vascular resistance index as a function of GFR level in patients with pulsatile cardiac output.
Detailed description
Extracorporeal assistance is recommended for patients with a potentially reversible acute risk of life that does not respond to conventional treatments. Hypoxic refractory syndromes, such as acute respiratory distress syndrome, are referred to as veno-venous ECMO (for Extracorporeal Membrane Oxygenation) (ECMO VV), whereas terminal cardiac dysfunctions require veno-arterial ECMO (VA ECMO). recovery of function (cardiotropic intoxication), or in the most severe cases, pending transplantation or long-term assistance.
This is a qualified pilot study, as it is the first one interested in evaluating the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft formula) by relative to the measured clearance of creatinine, a method that can be performed routinely in intensive care, for resuscitation patients under veno-arterial or veno-venous ECMO.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ECMO | Experimental | Diagnostic Test: Ultrasound for renal resistivity index measurementPatients with circulatory assistance by ECMO Patients are included 48 hours after ECMO VA or VV therapy and after hemodynamic stabilization defined by blood pressure stability and cardiac output for at least 12 hours without significant changes in amine flow. When stable they will have an Ultrasound for renal resistivity index measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18
- ECMO VV or VA after 48 hours of installation
- Hemodynamic stability for at least 12 hours
- Person affiliated or benefiting from a social security scheme
- Having expressed an express consent OR patient for whom a relative has given express consent
Key exclusion criteria (6 listed)
- Hemodynamic instability
- Chronic renal failure patients receiving dialysis
- Need for continuous or intermittent extra-renal cleansing
- Patients under the protection of justice
- Person participating in another search including an exclusion period still in progress
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 |
|---|---|---|
| Ultrasound for renal resistivity index measurementCollection of urine over 3 hours for creatinine clearance measurement, with serum creatinine in parallel with urine collection to calculate measured creatinine clearance and estimate glomerular filtration rate Evaluation of the renal vascular resistance index in Doppler ultrasound by a resuscitator trained in the technique at the time of inclusion. Collection of demographic, clinical and biological data for inclusion of the patient such as weight, age, sex, arterial lactatemia, arterial pH, volume status, use of diuretics, use of vasopressors, use of nephrotoxic drugs ... | Diagnostic test | Patients with ECMO |
Primary outcome
Compare the clearance of creatinine in urine with GFR
Time frame: 1 hour
Measured clearance of creatinine in urine (collected over 3 hours during haemodynamic stabilization of the patient) that will be compared to the Glomerular Filtration Rate(GFR) (estimated according to the Cockcroft and CKD-EPI formulas).
3 secondary outcomes
Number of patients in ECMO with augmented renal clearance (ARC)
Time frame: 1 hour
Index of renal vascular resistance
Time frame: 18 months
Differences in the variable GFR between patients with glomerular hypofiltration
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Stéphanie Ruiz, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound for renal resistivity index measurement in people with Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Toulouse 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Ruiz, MD (05 61 32 44 64 ext. 33, ruiz.stephanie@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the clearance of creatinine in urine with GFR (time frame: 1 hour). 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 23 Jul 2018.