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

Inflammation Clinical Trial

— ADRECMO  

Official title:

Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327493
• Other study ID #: 2016-A00707-44
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: May 24, 2022

Study information

• Verified date: April 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 24, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Extra-Corporeal-Life-Support ( ECLS)
• Inflammation
• Nervous System Diseases
• Primary Dysautonomias
• Shock
• Shock, Cardiogenic

Intervention

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: Adrenoreceptors a1, a2, ß1, ß2, ß3 on monocytes and lymphocytes T helper by flow cytometry Lymphocytes Th1/Th2 pattern by flow cytometry Cytokines on plasma : Interleukin (IL) 4, IL 12, TNF a, INF ? , IL1, IL6, IL10 Clinical assessment: Hemodynamic parameters Cumulated doses of catecholamines 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")

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cytokines (plasma TNF a, INF ?, IL4, IL 12, IL1 IL 6 IL 10)	Exposition variable will be the density of a1, a2, ß1, ß2, ß3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)	day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary	Change in hemodynamic parameters	Arterial pressures	day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary	Change in hemodynamic parameters	heart rate	day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary	Change in hemodynamic parameters	cumulated doses of catecholamines	day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary	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	day 3, day "ECLS weaning"
Secondary	Mortality		28 days and 90 days
Secondary	Change in TH1 and TH2 pattern	Assessment in CD3/CD4 + cells of INF ?; IL12 (TH1) and IL4 (TH2)	day 0 (ECLS initation), day 3, day "ECLS weaning"