CClinicalTrials.gg
CompletedNCT03262155IMPECUpdated Apr 12, 2023

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

An observational study in Acute Respiratory Distress Syndrome and Cardiogenic Shock, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • BiologicalBlood test
05

What researchers measure

Primary outcomes

  1. Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit

    Time frame: Hour 24

06

Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03262155
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Jan 1, 2017
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
Apr 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion