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Cardiogenic ShockNCT03283995

Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology

An observational study of Cardiogenic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The classic physiopathology of cardiogenic shock is explained by a systolic ventricular failure, responsible for a decrease in cardiac output associated with high systemic vascular resistances (SVR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
What is being tested?
Cardiac Volume Monitoring VolumeView and echocardiography
Type of treatment
Medical device
How many people
64 participants
Where
1 siteFrance
Study dates
6 Sep 2017to Mar 2019
How long will I take part?
2 Days
Phase
Observational
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

Study population: patients with cardiogenic shock.

Who may be able to join

  • Persistent hypotension (systolic blood pressure <90 mmHg for at least 30 minutes or need for vasopressor support)
  • Signs of visceral hypoperfusion (confusion, marbling, oliguria, hyperlactataemia), 11
  • Lower heart rate (<1.8 L / min / m2) Adap Suitable or high filling pressures12

Who cannot join

  • Pregnant or nursing women
  • Major under guardianship
  • Person staying in a health or social facility
  • Non-beneficiaries of a social security scheme
  • Persons deprived of liberty
  • No one is able to give consent.

Trial locations and contacts

1 site in 1 country.

laurent BONELLO contact

0491968683

laurent.bonello@ap-hm.fr

alexandra GIULIANI contact

04 91 38 27 47

drci@ap-hm.fr

France1 site, 1 recruiting
  • Assisatnce Publique Hopitaux de Marseille

    Marseille

    JEAN-OLIVIER ARNAUD, drci@ap-hm.fr

    LAURENT BONELLO

    Recruiting

Other trials in France

About this study

The classic physiopathology of cardiogenic shock is explained by a systolic ventricular failure, responsible for a decrease in cardiac output associated with high systemic vascular resistances (SVR). This theory is currently challenged in light of the data collected in the SHOCK study, which assessed outcome of early revascularization versus initial medical stabilization, in cardiogenic shock following myocardial infarction.13 A sub-study highlighted depressed SVR in the population with ischemic cardiogenic shock, related to a systemic inflammatory response syndrome.14 Furthermore, mean FEVG was 30% in the SHOCK trial,13 with a similar distribution with post myocardial infarction heart failure patients without signs of shock.15-19 Thus, alteration of myocardial contractility can be only moderate in cardiogenic shock and isn't the only cause responsible for the hemodynamic instability.20 Recent studies suggest the important roles of the peripheral vascular system and neurohormonal system in the genesis and prolongation of cardiogenic shock.12 Vasodilation caused by nitrous oxide synthase activation27 explains the absence of compensating vasoconstriction observed during the SHOCK trial13, and leads to decreased systemic and coronary perfusion, thus increasing myocardial ischemia and initial ventricular dysfunction. 28,29 Cotter et al. conducted an interesting study of hemodynamic evaluation of various cardiac conditions where they observed a significant variability in the peripheral vascular status, with systemic vascular resistances collapsed in certain patients (similar to those observed in septic shock) and rather close to normal or very high resistances in other patients.21 However these data were obtained from a selected group of patients without differentiating the etiology of cardiogenic shock. Finally, the majority of available studies were limited to cardiogenic shock whose etiology was myocardial infarction.

Therapeutic management of cardiogenic shock is based in first intention on an inotropic support by Dobutamine.11,23 However, better outcomes on contractility and microcirculatory state have been observed with the use of a vasopressor support by Norepinephrine, suggesting the importance of SVR decreasing in genesis of cardiogenic shock.14,24 Recent reviews showed very few data on inotropic treatment and association with vasopressor support,22 hence the low level of recommendations in current guidelines.11,23

Read more

So far it is crucial to accurately characterize hemodynamic status and in particular the systemic vascular resistance for patients with cardiogenic shock. Important variabilities in hemodynamic profiles observed in Cooter's trial could explain the difficulty in defining an optimal therapeutic strategy.

the investigators hypothesize that the hemodynamic profile, particularly SVR, of patients with cardiogenic shock is different depending on their etiology. Ischemic cardiogenic shock should be characterized by lower SVR, in relation to a major role of systemic inflammatory response syndrome. On the contrary, non-ischemic cardiogenic shock could be associated with normal or elevated SVR, and thus could explain the variability in distribution of SVR.

Being tested
Cardiac Volume Monitoring VolumeView, echocardiography
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Volume Monitoring VolumeViewOther

    hemodynamic measure

  • echocardiographyDevice

    hemodynamic measure

Study groups in NCT03283995
Study groupRoleWhat they receive
cardiogenic shock without SCANot described
Receives: Other: Cardiac Volume Monitoring VolumeView; Device: echocardiography
cardiogenic shock with SCANot described
Receives: Other: Cardiac Volume Monitoring VolumeView; Device: echocardiography
SCA,Not described
Receives: Device: echocardiography
acute left heart failure with severe alteration of LVEFNot described
Receives: Device: echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monitoring by transpulmonary thermodilution (VolumeView

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start6 Sep 2017
  3. Primary completionSep 2018 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
64 participants (estimated)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283995
Sponsor's protocol ID
2017-15
Other IDs
2017-A00563-50
Status last verified
Apr 2018
First submitted
13 Sep 2017
Last updated
11 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock, run by Assistance Publique Hopitaux De Marseille 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 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact laurent BONELLO (0491968683, laurent.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monitoring by transpulmonary thermodilution (VolumeView (time frame: 2 days). 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 11 Apr 2018.

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