Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance

NCT ID: NCT03525483

Last Updated: 2018-07-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Extracorporeal Membrane Oxygenation Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

Ultrasound for renal resistivity index measurement

Intervention Type DIAGNOSTIC_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 ...

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 ...

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphanie Ruiz, MD

Role: CONTACT

05 61 32 44 64 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

05 61 77 70 51 ext. 33

Facility Contacts

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Stéphanie Ruiz, MD

Role: primary

05 61 32 44 64 ext. 33

Isabelle Olivier, PhD

Role: backup

05 61 77 70 51 ext. 33

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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