Transient Circulatory Support in Cardiogenic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-12

Study Completion Date

2021-10-31

Brief Summary

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The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Some studies described patients with TCS in order to establish mortality predictive scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS decision yet. Therefore, The investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by the heart team.

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Detailed Description

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This French multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (TCS) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment.

All patients with cardiogenic shock for whom indication of TCS was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study.

Two groups of patients are defined:

* Patients with cardiogenic shock treated by medical treatement
* Patients with cardiogenic shock treated by TCS (extracorporeal circulatory life support and/or Impella).

The main objective is to compare mortality between the 2 groups. Secondary objectives are ICU follow-up characteristics and quality of life questionnaire at day 180.

Statistical analysis will include a propensity-matched method to compare the groups to avoid confounding factors. The number of necessary subjects (n=240, 120 in each group) was calculated assuming that TCS has a superiority of 20% in comparison with medical treatment in severe cardiogenic shock, with a study power of 80%, and an alpha risk of 5%.

Conditions

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Acute Cardiogenic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiogenic shock treated with medical treatment

Patients with cardiogenic shock treated only by medical treatment

No interventions assigned to this group

Cardiogenic shock treated with transient circulatory support

Patients where transient circulatory support was implanted: veno-arterial extracorporeal circulatory life support (ECLS), Impella

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Cardiogenic shock :

• Systolic BP\<90mmHg despite adequate filling pressure
* Or need of cathecolamines to maintain SBP \> 90mmHg

* Signs of right-sided and/or left-sided congestion
* Signs of tissue hypoperfusion : oliguria, cold sweated extremities, mental confusion, dizziness, narrow pulse pressure, blood lactate \> 2 mmol/L
* Short-term mechanical circulatory support discussed by the multidisciplinary heart team

Exclusion Criteria

* Post cardiotomy cardiogenic shock
* Refractory cardiac arrest
* Cardiac Arrest with No Flow \>3 min and/or non shokable rythm
* Contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation
* Pregnant or brest-feeding women,
* Age \< 18 year-old

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No