Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance
NCT ID: NCT03525483
Last Updated: 2018-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-07-19
2019-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with ECMO
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
Ultrasound for renal resistivity index measurement
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 ...
Interventions
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Ultrasound for renal resistivity index measurement
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 ...
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Stéphanie Ruiz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A00907-48
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/18/0127
Identifier Type: -
Identifier Source: org_study_id
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