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

Completed

• Conditions: Acute Respiratory Distress Syndrome; Cardiogenic Shock
• Interventions: Biological: Blood test

• Registration Number: NCT03262155
• Lead Sponsor: Rennes University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No ECMO / ECLS	Blood test	Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS
ECMO / ECLS	Blood test	Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS

Primary Outcome Measures

Name	Time	Method
Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit	Hour 24

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France