Clinical trial NCT03327493: Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO
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
Overall status: COMPLETED
Phase: NA
Conditions: Shock, Cardiogenic
Extra-Corporeal-Life-Support ( ECLS)
Autonomic Nervous System Diseases
Inflammation
Keywords: Cardiogenic shock
Extra-Corporeal-Life-Support (ECLS)
inflammation
adrenergic system
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-10-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)
timeFrame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary outcomes:
measure: Change in hemodynamic parameters
timeFrame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
measure: Change in hemodynamic parameters
timeFrame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
measure: Change in hemodynamic parameters
timeFrame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
measure: Cardiac output variation during a weaning ECLS procedure
timeFrame: day 3, day "ECLS weaning"
measure: Mortality
timeFrame: 28 days and 90 days
measure: Change in TH1 and TH2 pattern
timeFrame: day 0 (ECLS initation), day 3, day "ECLS weaning"
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Antoine Kimmoun, MD
role: PRINCIPAL_INVESTIGATOR
References: