Transient Circulatory Support in Cardiogenic Shock

Acute Cardiogenic Shock Clinical Trial

— ALLOASSIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528291
• Other study ID #: 9842
• Status: Recruiting
• Start date: July 12, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: Jacob ELIET, M.D
• Phone: 0467335946
• Email: j-eliet[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
France	Department of Anesthesia-Resuscitation Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	Mortality rate in the 2 groups at the time of hospital discharge	From inclusion day to day 180
Secondary	Short term mortality rate	Mortality rate at day 28	From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first
Secondary	Acute renal failure	Incidence of renal replacement therapy	From inclusion day to ICU discharge or day 28 whichever came first
Secondary	Respiratory failure	Days of mechanical ventilation	From inclusion day to ICU discharge or day 28 whichever came first
Secondary	Thromboembolic events	Incidence of stroke, peripheral or mesenteric ischemia	From inclusion day to ICU discharge or day 28 whichever came first
Secondary	Bleeding events	Incidence of red blood cell transfusion	From inclusion day to ICU discharge or day 28 whichever came first
Secondary	ICU stays	Length of stay in ICU (number of days)	From inclusion day to day 180
Secondary	Hospital stays	Length of stay in hospital (number of days)	From inclusion day to day 180
Secondary	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
Secondary	Long term mortality rate	Mortality rate at day 180	From inclusion day to day 180