Transient Circulatory Support in Cardiogenic Shock

Study Overview
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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.

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%.

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

Conditions
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Acute Cardiogenic Shock

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | Mortality rate in the 2 groups at the time of hospital discharge | From inclusion day to day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term mortality rate | Mortality rate at day 28 | From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first | 
| Acute renal failure | Incidence of renal replacement therapy | From inclusion day to ICU discharge or day 28 whichever came first | 
| Respiratory failure | Days of mechanical ventilation | From inclusion day to ICU discharge or day 28 whichever came first | 
| Thromboembolic events | Incidence of stroke, peripheral or mesenteric ischemia | From inclusion day to ICU discharge or day 28 whichever came first | 
| Bleeding events | Incidence of red blood cell transfusion | From inclusion day to ICU discharge or day 28 whichever came first | 
| ICU stays | Length of stay in ICU (number of days) | From inclusion day to day 180 | 
| Hospital stays | Length of stay in hospital (number of days) | From inclusion day to day 180 | 
| Quality of life score SF 36 | 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. | From inclusion day to day 180 | 
| Long term mortality rate | Mortality rate at day 180 | From inclusion day to day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human,, adult,, intensive care unit,, cardiogenic shock,, Transient circulatory support,, extra corporeal life support, Impella