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

Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance: Estimation Formula Versus Measured Clearance of Creatinine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03525483
Acronym
CREA-ECMO
Enrollment
100
Registered
2018-05-15
Start date
2018-07-19
Completion date
2019-11-30
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

ECMO, Acute renal failure

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.

Interventions

DIAGNOSTIC_TESTUltrasound 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 ...

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compare the clearance of creatinine in urine with GFR1 hourMeasured 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).

Secondary

MeasureTime frameDescription
Number of patients in ECMO with augmented renal clearance (ARC)1 hourIn 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.
Index of renal vascular resistance18 monthsindex of renal vascular resistance obtained by Doppler ultrasound by a resuscitator trained in the technique at the time of inclusion.
Differences in the variable GFR between patients with glomerular hypofiltration18 monthsDifferences 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).

Countries

France

Contacts

Primary ContactStéphanie Ruiz, MD
ruiz.stephanie@chu-toulouse.fr05 61 32 44 64
Backup ContactIsabelle Olivier, PhD
olivier.i@chu-toulouse.fr05 61 77 70 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026