An observational study in Acute Cardiogenic Shock, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by University Hospital, Montpellier · Observational
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%.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's planned enrollment of 240 is above the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team
Cardiogenic shock :
Or need of cathecolamines to maintain SBP > 90mmHg
Exclusion Criteria:
Patients with cardiogenic shock treated only by medical treatment
Patients where transient circulatory support was implanted: veno-arterial extracorporeal circulatory life support (ECLS), Impella
Hospital Mortality
Mortality rate in the 2 groups at the time of hospital discharge
Time frame: From inclusion day to day 180
Short term mortality rate
Mortality rate at day 28
Time frame: From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first
Acute renal failure
Incidence of renal replacement therapy
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Respiratory failure
Days of mechanical ventilation
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Thromboembolic events
Incidence of stroke, peripheral or mesenteric ischemia
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Bleeding events
Incidence of red blood cell transfusion
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
ICU stays
Length of stay in ICU (number of days)
Time frame: From inclusion day to day 180
Hospital stays
Length of stay in hospital (number of days)
Time frame: 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.
Time frame: From inclusion day to day 180
Long term mortality rate
Mortality rate at day 180
Time frame: From inclusion day to day 180
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier