An interventional study of Biological in Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS) and Autonomic Nervous System Diseases, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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cardiogenic shock
Exclusion Criteria:
Patients under ECLS for a/an :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Biological
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")
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)
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
Arterial pressures
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
heart rate
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
cumulated doses of catecholamines
Time frame: 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: * 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
Time frame: day 3, day "ECLS weaning"
Mortality
Time frame: 28 days and 90 days
Change in TH1 and TH2 pattern
Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)
Time frame: day 0 (ECLS initation), day 3, day "ECLS weaning"
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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