Clinical trial NCT03525483: Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance
Official title: Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance: Estimation Formula Versus Measured Clearance of Creatinine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: ECMO
Acute renal failure
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the clearance of creatinine in urine with GFR
timeFrame: 1 hour
Secondary outcomes:
measure: Number of patients in ECMO with augmented renal clearance (ARC)
timeFrame: 1 hour
measure: Index of renal vascular resistance
timeFrame: 18 months
measure: Differences in the variable GFR between patients with glomerular hypofiltration
timeFrame: 18 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Stéphanie Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
References: