Autonomic Nervous System Diseases, Extra-Corporeal-Life-Support ( ECLS), Inflammation, Shock, Cardiogenic
Conditions
Keywords
Cardiogenic shock, Extra-Corporeal-Life-Support (ECLS), inflammation, adrenergic system
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
Interventions
DIAGNOSTIC_TESTBiological
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)
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day ECLS weaning for various biological variables
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in hemodynamic parameters | day 0 (ECLS initiation), day 3, day ECLS weaning | Arterial pressures |
| 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 |
| 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) |
Countries
France
Outcome results
None listed