Shock, CardiogenicADRECMONCT03327493
Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO
A study testing Biological in people with Shock, Cardiogenic and Extra-Corporeal-Life-Support ( ECLS), run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS), Autonomic Nervous System Diseases
- What is being tested?
- Biological
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2017to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients under ECLS for a/an :
- Cardiotoxic poisoning
- Human immunodeficient Virus or Viral hepatitis C
- Patient < 18 yo
- Pregnancy
- Patient under protective supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation
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.
Read the detailed description
NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned
- Conditions
- Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS), Autonomic Nervous System Diseases, Inflammation
- Being tested
- Biological
- Keywords
- Cardiogenic shock, Extra-Corporeal-Life-Support (ECLS), inflammation, adrenergic system
- Medical subject headings
- Shock, Cardiogenic, Autonomic Nervous System Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicalDiagnostic 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")
| Study group | Role | What they receive |
|---|---|---|
| Refractory cardiogenic shock under ECLS | Other | Not described Receives: Diagnostic Test: Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Secondary outcomes (6)
Change in hemodynamic parameters
Arterial pressures
Measured: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
heart rate
Measured: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
cumulated doses of catecholamines
Measured: 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
Measured: day 3, day "ECLS weaning"
Mortality
Measured: 28 days and 90 days
Change in TH1 and TH2 pattern
Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)
Measured: day 0 (ECLS initation), day 3, day "ECLS weaning"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start10 Oct 2017
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, CardiogenicStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Antoine KIMMOUN, Central Hospital, Nancy, France
- Investigators
- Antoine Kimmoun, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327493
- Sponsor's protocol ID
- 2016-A00707-44
- Acronym
- ADRECMO
- Status last verified
- Apr 2023
- First submitted
- 21 Sep 2017
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03327493
- Acronym / sponsor ID
- ADRECMO / 2016-A00707-44
- Conditions
- Shock, Cardiogenic, Extra-Corporeal-Life-Support ( ECLS), Autonomic Nervous System Diseases, Inflammation
- Keywords
- Cardiogenic shock, Extra-Corporeal-Life-Support (ECLS), inflammation, adrenergic system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables
| Arm | Type | Receives |
|---|---|---|
| Refractory cardiogenic shock under ECLS | Other | Diagnostic Test: Biological |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients in ICU
- Refractory cardiogenic shock
- needing an Extra-Corporeal-Life-Support
- informed consent from relatives or patient
- Affiliation to a social security regimen
Key exclusion criteria (6 listed)
- Patients under ECLS for a/an :
- Human immunodeficient Virus or Viral hepatitis C
- Patient < 18 yo
- Pregnancy
- Patient under protective supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiologicalWe 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") | Diagnostic test | Refractory cardiogenic shock under ECLS |
Primary outcome
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)
6 secondary outcomes
Change in hemodynamic parameters
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Change in hemodynamic parameters
Time frame: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Cardiac output variation during a weaning ECLS procedure
Time frame: day 3, day "ECLS weaning"
Mortality
Time frame: 28 days and 90 days
Change in TH1 and TH2 pattern
Time frame: day 0 (ECLS initation), day 3, day "ECLS weaning"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Kimmoun, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological in people with Shock, Cardiogenic and Extra-Corporeal-Life-Support ( ECLS), run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.