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Completed

NCT Number: NCT03327493

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

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.

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Key information

Conditions

Shock, Cardiogenic Autonomic Nervous System Diseases Cardiovascular Diseases Extra-Corporeal-Life-Support ( ECLS) Heart Diseases Infarction Inflammation Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Nancy, 54000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Adrenoreceptors α1, α2, β1, β2, β3 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 α, INF γ , 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")

Primary outcomes

  1. Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)

    Time frame: 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 outcomes

  1. Change in hemodynamic parameters

    Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"

    Arterial pressures

  2. Change in hemodynamic parameters

    Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"

    heart rate

  3. Change in hemodynamic parameters

    Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"

    cumulated doses of catecholamines

  4. Cardiac output variation during a weaning ECLS procedure

    Time frame: 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

  5. Mortality

    Time frame: 28 days and 90 days

  6. Change in TH1 and TH2 pattern

    Time frame: day 0 (ECLS initation), day 3, day "ECLS weaning"

    Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: ADRECMO

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2017
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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