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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2022-05-24

Brief Summary

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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.

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Detailed Description

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NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Refractory cardiogenic shock under ECLS

Group Type OTHER

Biological

Intervention Type DIAGNOSTIC_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")

Interventions

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Biological

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")

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No