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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory cardiogenic shock under ECLS | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological | 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:
Clinical assessment:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10) | Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper) | day 0 (ECLS initiation), day 3, day "ECLS weaning" |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemodynamic parameters | Arterial pressures | day 0 (ECLS initiation), day 3, day "ECLS weaning" |
| Change in hemodynamic parameters | heart rate |
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Inclusion Criteria:
Patients in ICU
Refractory cardiogenic shock
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 :
Human immunodeficient Virus or Viral hepatitis C
Patient < 18 yo
Pregnancy
Patient under protective supervision
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Kimmoun, MD | CHRU Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Nancy | 54000 | France |
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Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
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|
| day 0 (ECLS initiation), day 3, day "ECLS weaning" |
| Change in hemodynamic parameters | cumulated doses of catecholamines | day 0 (ECLS initiation), day 3, day "ECLS weaning" |
| Cardiac output variation during a weaning ECLS procedure | At a constant mean arterial pressure (65-75 mmHg), measurement by echocardiography of cardiac output at 2 times:
| day 3, day "ECLS weaning" |
| Mortality | 28 days and 90 days |
| Change in TH1 and TH2 pattern | Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2) | day 0 (ECLS initation), day 3, day "ECLS weaning" |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D001342 | Autonomic Nervous System Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D009422 | Nervous System Diseases |
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