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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.
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:
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital Mortality | Mortality rate in the 2 groups at the time of hospital discharge | From inclusion day to day 180 |
| 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 |
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Inclusion Criteria:
Cardiogenic shock :
• Systolic BP<90mmHg despite adequate filling pressure
Or need of cathecolamines to maintain SBP > 90mmHg
Short-term mechanical circulatory support discussed by the multidisciplinary heart team
Exclusion Criteria:
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Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob ELIET, M.D | Contact | 0467335946 | j-eliet@chu-montpellier.fr | |
| Pascal COLSON, M.D; Ph.D | Contact | 0467335957 | p-colson@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jacob ELIET, M.D | Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia-Resuscitation Arnaud de Villeneuve | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367739 | Derived | Ughetto A, Eliet J, Nagot N, David H, Bazalgette F, Marin G, Kollen S, Mourad M, Zeroual N, Muller L, Gaudard P, Colson P. Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network. J Heart Lung Transplant. 2024 Jun;43(6):911-919. doi: 10.1016/j.healun.2024.02.009. Epub 2024 Feb 15. |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |