NCT03262155

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

August 23, 2017

Last Update Submit

April 11, 2023

Conditions

Acute Respiratory Distress SyndromeCardiogenic Shock

Outcome Measures

Primary Outcomes (1)

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

    Hour 24

Study Arms (2)

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

Blood testBIOLOGICAL
ECMO / ECLSNo ECMO / ECLS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Respiratory Distress SyndromeShock, Cardiogenic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

January 1, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)