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

Central Hospital, Nancy, France

Status: Completed

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

Treatments: Diagnostic Test: Biological

Study type: Interventional

Funder types: Other

Identifiers

NCT03327493

2016-A00707-44

Details and patient eligibility

About

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.

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Refractory cardiogenic shock under ECLS

Other group

Treatment:

Diagnostic Test: Biological