Clinical trial NCT05309980: Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
Official title: Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Short Term Mechanical Circulatory Support
Shock Team
Keywords: Extra Corporeal Membrane Oxygenation
Cardiogenic Shock
Impella
Shock Team
Long Term Mechanical Circulatory Support
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with refractory cardiogenic shock treated with short term mechanical circulatory support between January 2007 to April 2019. A two months wash out period following shock team initiation (February and March 2013) has been set.

Brief summary: In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.

Detailed description: Short Term Mechanical Circulatory Support (STMCS) are the last resort therapeutics when refractory cardiogenic shock occurs. Growing technical possibilities like impella make the right choice at the right time challenging. At Bordeaux University Hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in January 2013. From that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. The objective of this study is to perform a before-after comparison between decision of STMCS for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from April 2013 to April 2019.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cardiogenic shock
* \>1 sign of refractory cardiogenic shock : Dobutamine \>10µg/kg/mn, epinephrine\>0.25µg/kg/mn or Milrinone \> 0.5µg/kg/mn ; ScvO2\<55% ; pO2/FiO2\<100
* No major counter indication to short term mechanical circulatory support : SOFA score \> 15, prolonged cardiac arrest, severe chronic disease, direct LVAD implantation or heart transplantation, counter indication for systemic anticoagulation

Exclusion Criteria:

* Age \< 18years
* Post cardiotomy cardiogenic shock
* Implantation of Impella 2.5 alone
* Implantation of Intra Aortic Balloon Pump alone

Primary outcomes:
measure: Vital status
timeFrame: One year after short term mechanical circulatory support initiation
Secondary outcomes:
measure: Vital status
timeFrame: 30 days after short term mechanical circulatory support initiation
measure: Vital status
timeFrame: 3 months after short term mechanical circulatory support initiation
measure: Vital status
timeFrame: 6 months after short term mechanical circulatory support initiation
measure: Lenght of stay
timeFrame: up to Intensive Care Unit discharge, an average of 15 days
measure: Lenght of stay
timeFrame: up to one year
measure: Long term mechanical circulatory support
timeFrame: up to intensive care unit discharge, an average of 15 days
measure: Heart transplantation
timeFrame: up to intensive care unit discharge, an average of 15 days
measure: Weaning from short term mechanical circulatory support
timeFrame: up to seven days from weaning attempt
measure: New renal replacement therapy
timeFrame: up to intensive care unit discharge, an average of 15 days
measure: Limb ischaemia
timeFrame: through short term mechanical circulatory support weaning, an average of 6 days
measure: Stroke
timeFrame: through short term mechanical circulatory support weaning, an average of 6 days
measure: Short term mechanical circulatory support duration
timeFrame: through short term mechanical circulatory support weaning, an average of 6 days
measure: Severe haemorrage
timeFrame: through short term mechanical circulatory support weaning, an average of 6 days
measure: Extra Corporeal Membrane Oxygenation circuit clotting
timeFrame: through short term mechanical circulatory support weaning, an average of 6 days
measure: Sepsis
timeFrame: up to intensive care unit discharge, an average of 15 days
measure: Vital status
timeFrame: One year after short term mechanical circulatory support initiation
measure: Vital status
timeFrame: 30 days after short term mechanical circulatory support initiation
measure: Vital status
timeFrame: 3 months after short term mechanical circulatory support initiation
measure: Vital status
timeFrame: 6 months after short term mechanical circulatory support initiation
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandre Ouattara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: