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Transient Circulatory Support in Cardiogenic Shock (ALLOASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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
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%.

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Study Type : Observational
Estimated 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 : July 12, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
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



Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: From inclusion day to day 180 ]
    Mortality rate in the 2 groups at the time of hospital discharge


Secondary Outcome Measures :
  1. 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

  2. Acute renal failure [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]
    Incidence of renal replacement therapy

  3. Respiratory failure [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]
    Days of mechanical ventilation

  4. Thromboembolic events [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]
    Incidence of stroke, peripheral or mesenteric ischemia

  5. Bleeding events [ Time Frame: From inclusion day to ICU discharge or day 28 whichever came first ]
    Incidence of red blood cell transfusion

  6. ICU stays [ Time Frame: From inclusion day to day 180 ]
    Length of stay in ICU (number of days)

  7. Hospital stays [ Time Frame: From inclusion day to day 180 ]
    Length of stay in hospital (number of days)

  8. 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.


  9. Long term mortality rate [ Time Frame: From inclusion day to day 180 ]
    Mortality rate at day 180



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jacob ELIET, M.D 0467335946 j-eliet@chu-montpellier.fr
Contact: Pascal COLSON, M.D; Ph.D 0467335957 p-colson@chu-montpellier.fr

Locations
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France
Department of Anesthesia-Resuscitation Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Jacob ELIET, M.D    0467335946    j-eliet@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jacob ELIET, M.D Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03528291    
Other Study ID Numbers: 9842
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Human,
adult,
intensive care unit,
cardiogenic shock,
Transient circulatory support,
extra corporeal life support
Impella
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases