Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS) (IMPEC)

August 23, 2017 updated by: Rennes University Hospital
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for ARDS or Cardiogenic shock with or without ECMO / ECLS

Description

Inclusion Criteria:

  • Patient older than 18 years old
  • Patient hospitalized in an intensive care unit
  • Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission
  • Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS

Exclusion Criteria:

  • Opposition of patient, relative or legal representative for participation in the study
  • Pregnant woman
  • Pre-immunodepression
  • Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (> 0.5mg / kg / day).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMO / ECLS
Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS
Biological: Blood test
No ECMO / ECLS
Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS
Biological: Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit
Time Frame: Hour 24
Hour 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2016

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC16_3037_IMPECstudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome

Clinical Trials on Blood test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe