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

Not Applicable

Completed

• Conditions: Extra-Corporeal-Life-Support ( ECLS); Inflammation; Autonomic Nervous System Diseases; Shock, Cardiogenic
• Interventions: Diagnostic Test: Biological

• Registration Number: NCT03327493
• Lead Sponsor: Central Hospital, Nancy, France

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

Study Timeline

• Study First Submitted: 2017-09-21
• Study Start: 2017-10-10
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Primary Completion: 2022-05-24
• Study Completion: 2022-05-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refractory cardiogenic shock under ECLS	Biological	-

Primary Outcome Measures

Name	Time	Method
Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)	day 0 (ECLS initiation), day 3, day "ECLS weaning"	Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)

Secondary Outcome Measures

Name	Time	Method
Cardiac output variation during a weaning ECLS procedure	day 3, day "ECLS weaning"	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
Change in hemodynamic parameters	day 0 (ECLS initiation), day 3, day "ECLS weaning"	cumulated doses of catecholamines
Mortality	28 days and 90 days
Change in TH1 and TH2 pattern	day 0 (ECLS initation), day 3, day "ECLS weaning"	Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France