Transient Circulatory Support in Cardiogenic Shock (ALLOASSIST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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%.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Jacob ELIET, M.D; Phone Number: 0467335946; Email: j-eliet@chu-montpellier.fr
• Study Contact Backup: Name: Pascal COLSON, M.D; Ph.D; Phone Number: 0467335957; Email: p-colson@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Department of Anesthesia-Resuscitation Arnaud de Villeneuve
    • Contact: Jacob ELIET, M.D; Phone Number: 0467335946; Email: j-eliet@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Jacob ELIET, M.D, Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Human,; adult,; intensive care unit,; cardiogenic shock,; Transient circulatory support,; extra corporeal life support; Impella
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 9842

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No