Clinical trial NCT03528291: Transient Circulatory Support in Cardiogenic Shock
Official title: Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Cardiogenic Shock
Keywords: Human,
adult,
intensive care unit,
cardiogenic shock,
Transient circulatory support,
extra corporeal life support
Impella
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team

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.

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%.

Eligibility 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

Primary outcomes:
measure: Hospital Mortality
timeFrame: From inclusion day to day 180
Secondary outcomes:
measure: Short term mortality rate
timeFrame: From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first
measure: Acute renal failure
timeFrame: From inclusion day to ICU discharge or day 28 whichever came first
measure: Respiratory failure
timeFrame: From inclusion day to ICU discharge or day 28 whichever came first
measure: Thromboembolic events
timeFrame: From inclusion day to ICU discharge or day 28 whichever came first
measure: Bleeding events
timeFrame: From inclusion day to ICU discharge or day 28 whichever came first
measure: ICU stays
timeFrame: From inclusion day to day 180
measure: Hospital stays
timeFrame: From inclusion day to day 180
measure: Quality of life score SF 36
timeFrame: From inclusion day to day 180
measure: Long term mortality rate
timeFrame: From inclusion day to day 180
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesia-Resuscitation Arnaud de Villeneuve
Study officials:
affiliation: Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve
name: Jacob ELIET, M.D
role: PRINCIPAL_INVESTIGATOR
References: