search
Back to results

Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO (ADRECMO)

Primary Purpose

Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS), Autonomic Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shock, Cardiogenic focused on measuring Cardiogenic shock, Extra-Corporeal-Life-Support (ECLS), inflammation, adrenergic system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in ICU

  • Refractory cardiogenic shock

    • Cardiogenic shock: Systolic Arterial Pressure <90mmHg, or Mean Arterial Pressure <65mmHg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index < 2.2 l/min/m2)
    • Refractory state: hypo responsiveness to norepinephrine AND/OR persisting profound hypo perfusion clinical symptoms despite optimal resuscitation
  • needing an Extra-Corporeal-Life-Support
  • informed consent from relatives or patient
  • Affiliation to a social security regimen
  • Preliminary medical examination

Exclusion Criteria:

  • Patients under ECLS for a/an :

    • Cardiotoxic poisoning
  • Human immunodeficient Virus or Viral hepatitis C
  • Patient < 18 yo
  • Pregnancy
  • Patient under protective supervision

Sites / Locations

  • CHRU Nancy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Refractory cardiogenic shock under ECLS

Arm Description

Outcomes

Primary Outcome Measures

Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)
Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)

Secondary Outcome Measures

Change in hemodynamic parameters
Arterial pressures
Change in hemodynamic parameters
heart rate
Change in hemodynamic parameters
cumulated doses of catecholamines
Cardiac output variation during a weaning ECLS procedure
At a constant mean arterial pressure (65-75 mmHg), measurement by echocardiography of cardiac output at 2 times: baseline (3L/min of ECLS flow) after 45 min at weaning output (1.5 L/min of ECLS flow) Variation of norepinephrine doses will be also recorded
Mortality
Change in TH1 and TH2 pattern
Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)

Full Information

First Posted
September 21, 2017
Last Updated
April 15, 2023
Sponsor
Central Hospital, Nancy, France
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT03327493
Brief Title
Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO
Acronym
ADRECMO
Official Title
Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.
Detailed Description
NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS), Autonomic Nervous System Diseases, Inflammation
Keywords
Cardiogenic shock, Extra-Corporeal-Life-Support (ECLS), inflammation, adrenergic system

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refractory cardiogenic shock under ECLS
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Biological
Intervention Description
We will assess in all patients under ECLS for the treatment of a cardiogenic shock at day 0 (ECLS initiation) day 3 and day "ECLS weaning" : Biological assessment: Adrenoreceptors α1, α2, β1, β2, β3 on monocytes and lymphocytes T helper by flow cytometry Lymphocytes Th1/Th2 pattern by flow cytometry Cytokines on plasma : Interleukin (IL) 4, IL 12, TNF α, INF γ , IL1, IL6, IL10 Clinical assessment: Hemodynamic parameters Cumulated doses of catecholamines Cardiac output variation measured by echocardiography during a standardized weaning procedure of ECLS at a constant mean arterial pressure (only on day 3 and Day "ECLS weaning")
Primary Outcome Measure Information:
Title
Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)
Description
Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)
Time Frame
day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary Outcome Measure Information:
Title
Change in hemodynamic parameters
Description
Arterial pressures
Time Frame
day 0 (ECLS initiation), day 3, day "ECLS weaning"
Title
Change in hemodynamic parameters
Description
heart rate
Time Frame
day 0 (ECLS initiation), day 3, day "ECLS weaning"
Title
Change in hemodynamic parameters
Description
cumulated doses of catecholamines
Time Frame
day 0 (ECLS initiation), day 3, day "ECLS weaning"
Title
Cardiac output variation during a weaning ECLS procedure
Description
At a constant mean arterial pressure (65-75 mmHg), measurement by echocardiography of cardiac output at 2 times: baseline (3L/min of ECLS flow) after 45 min at weaning output (1.5 L/min of ECLS flow) Variation of norepinephrine doses will be also recorded
Time Frame
day 3, day "ECLS weaning"
Title
Mortality
Time Frame
28 days and 90 days
Title
Change in TH1 and TH2 pattern
Description
Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)
Time Frame
day 0 (ECLS initation), day 3, day "ECLS weaning"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in ICU Refractory cardiogenic shock Cardiogenic shock: Systolic Arterial Pressure <90mmHg, or Mean Arterial Pressure <65mmHg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index < 2.2 l/min/m2) Refractory state: hypo responsiveness to norepinephrine AND/OR persisting profound hypo perfusion clinical symptoms despite optimal resuscitation needing an Extra-Corporeal-Life-Support informed consent from relatives or patient Affiliation to a social security regimen Preliminary medical examination Exclusion Criteria: Patients under ECLS for a/an : Cardiotoxic poisoning Human immunodeficient Virus or Viral hepatitis C Patient < 18 yo Pregnancy Patient under protective supervision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Kimmoun, MD
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO

We'll reach out to this number within 24 hrs