NCT03525483

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

April 16, 2018

Last Update Submit

July 19, 2018

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

ECMOAcute renal failure

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 hour

Secondary Outcomes (3)

  • Number of patients in ECMO with augmented renal clearance (ARC)

    1 hour

  • Index of renal vascular resistance

    18 months

  • Differences in the variable GFR between patients with glomerular hypofiltration

    18 months

Study Arms (1)

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

Diagnostic Test: Ultrasound for renal resistivity index measurement

Interventions

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 ...

Patients with ECMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hemodynamic instability
  • Chronic renal failure patients receiving dialysis
  • Need for continuous or intermittent extra-renal cleansing
  • Patients under the protection of justice
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Stéphanie Ruiz, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Ruiz, MD

CONTACT

05 61 32 44 64ruiz.stephanie@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51olivier.i@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 15, 2018

Study Start

July 19, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)