ALLOASSIST: Transient Circulatory Support in Cardiogenic Shock

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT03528291

Collaborator

(none)

240

Enrollment

Location

51.6

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cardiogenic Shock

Detailed 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%.

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up

Actual Study Start Date :

Jul 12, 2017

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cardiogenic shock treated with medical treatment Patients with cardiogenic shock treated only by medical treatment
Cardiogenic shock treated with transient circulatory support Patients where transient circulatory support was implanted: veno-arterial extracorporeal circulatory life support (ECLS), Impella

Outcome Measures

Primary Outcome Measures

Hospital Mortality [From inclusion day to day 180]
Mortality rate in the 2 groups at the time of hospital discharge

Secondary Outcome Measures

Short term mortality rate [From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first]
Mortality rate at day 28
Acute renal failure [From inclusion day to ICU discharge or day 28 whichever came first]
Incidence of renal replacement therapy
Respiratory failure [From inclusion day to ICU discharge or day 28 whichever came first]
Days of mechanical ventilation
Thromboembolic events [From inclusion day to ICU discharge or day 28 whichever came first]
Incidence of stroke, peripheral or mesenteric ischemia
Bleeding events [From inclusion day to ICU discharge or day 28 whichever came first]
Incidence of red blood cell transfusion
ICU stays [From inclusion day to day 180]
Length of stay in ICU (number of days)
Hospital stays [From inclusion day to day 180]
Length of stay in hospital (number of days)
Quality of life score SF 36 [From inclusion day to day 180]
Quality of life, evaluated by the Short Form Survey scoring (SF36 score) using the RAND 36-Item Health Survey 1.0, which will be sent by mail at day 180 after inclusion. The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Long term mortality rate [From inclusion day to day 180]
Mortality rate at day 180

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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