Transient Circulatory Support in Cardiogenic Shock (ALLOASSIST)

University Hospital Center (CHU)

Status

Unknown

Conditions

Acute Cardiogenic Shock

Study type

Observational

Funder types

Other

Identifiers

NCT03528291

9842

Details and patient eligibility

About

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.

Full description

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%.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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