NCT03327493

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 21, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

September 21, 2017

Last Update Submit

April 15, 2023

Conditions

Shock, CardiogenicExtra-Corporeal-Life-Support ( ECLS)Autonomic Nervous System DiseasesInflammation

Keywords

Cardiogenic shockExtra-Corporeal-Life-Support (ECLS)inflammationadrenergic system

Outcome Measures

Primary Outcomes (1)

  • 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)

    day 0 (ECLS initiation), day 3, day "ECLS weaning"

Secondary Outcomes (6)

  • Change in hemodynamic parameters

    day 0 (ECLS initiation), day 3, day "ECLS weaning"

  • Change in hemodynamic parameters

    day 0 (ECLS initiation), day 3, day "ECLS weaning"

  • Change in hemodynamic parameters

    day 0 (ECLS initiation), day 3, day "ECLS weaning"

  • Cardiac output variation during a weaning ECLS procedure

    day 3, day "ECLS weaning"

  • Mortality

    28 days and 90 days

  • +1 more secondary outcomes

Study Arms (1)

Refractory cardiogenic shock under ECLS

OTHER
Diagnostic Test: Biological

Interventions

BiologicalDIAGNOSTIC_TEST

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: 1. Adrenoreceptors α1, α2, β1, β2, β3 on monocytes and lymphocytes T helper by flow cytometry 2. Lymphocytes Th1/Th2 pattern by flow cytometry 3. Cytokines on plasma : Interleukin (IL) 4, IL 12, TNF α, INF γ , IL1, IL6, IL10 Clinical assessment: 1. Hemodynamic parameters 2. Cumulated doses of catecholamines 3. 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")

Refractory cardiogenic shock under ECLS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients under ECLS for a/an :
  • Cardiotoxic poisoning
  • Human immunodeficient Virus or Viral hepatitis C
  • Patient \< 18 yo
  • Pregnancy
  • Patient under protective supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Shock, CardiogenicAutonomic Nervous System DiseasesInflammation

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockNervous System Diseases

Study Officials

  • Antoine Kimmoun, MD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PU-PH

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 31, 2017

Study Start

October 10, 2017

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)