Transient Circulatory Support in Cardiogenic Shock (ALLOASSIST)
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|ClinicalTrials.gov Identifier: NCT03528291|
Recruitment Status : Unknown
Verified February 2018 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
|Condition or disease|
|Acute Cardiogenic Shock|
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 Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up|
|Actual Study Start Date :||July 12, 2017|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
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
- Hospital Mortality [ Time Frame: From inclusion day to day 180 ]Mortality rate in the 2 groups at the time of hospital discharge
- Short term mortality rate [ Time Frame: From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first ]Mortality rate at day 28
- Acute renal failure [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]Incidence of renal replacement therapy
- Respiratory failure [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]Days of mechanical ventilation
- Thromboembolic events [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]Incidence of stroke, peripheral or mesenteric ischemia
- Bleeding events [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]Incidence of red blood cell transfusion
- ICU stays [ Time Frame: From inclusion day to day 180 ]Length of stay in ICU (number of days)
- Hospital stays [ Time Frame: From inclusion day to day 180 ]Length of stay in hospital (number of days)
- Quality of life [ Time Frame: 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 [ Time Frame: From inclusion day to day 180 ]Mortality rate at day 180
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528291
|Contact: Jacob ELIET, M.Demail@example.com|
|Contact: Pascal COLSON, M.D; Ph.Dfirstname.lastname@example.org|
|Department of Anesthesia-Resuscitation Arnaud de Villeneuve||Recruiting|
|Montpellier, France, 34295|
|Contact: Jacob ELIET, M.D 0467335946 email@example.com|
|Principal Investigator:||Jacob ELIET, M.D||Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve|