Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
- Conditions
- Cardiogenic ShockShort Term Mechanical Circulatory SupportShock Team
- Interventions
- Other: standard of care
- Registration Number
- NCT05309980
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- Age < 18years
- Post cardiotomy cardiogenic shock
- Implantation of Impella 2.5 alone
- Implantation of Intra Aortic Balloon Pump alone
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description With Shock Team standard of care After April 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device following a collegial meeting of a shock team (cardiac surgeon, cardiologist, intensivist) using a common algorythm. Without Shock Team standard of care Before January 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device without involvment of a dedicated shock team
- Primary Outcome Measures
Name Time Method Vital status One year after short term mechanical circulatory support initiation Proportion of patients alive
- Secondary Outcome Measures
Name Time Method Vital status 6 months after short term mechanical circulatory support initiation proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
Long term mechanical circulatory support up to intensive care unit discharge, an average of 15 days proportion of patients bridged to long term mechanical circulatory support
Heart transplantation up to intensive care unit discharge, an average of 15 days proportion of patients bridged to heart transplantation
Weaning from short term mechanical circulatory support up to seven days from weaning attempt proportion of patients sucessfully weaned from short term mechanical circulatory support
Stroke through short term mechanical circulatory support weaning, an average of 6 days proportion of patients with stroke
Lenght of stay up to one year Hospital length of stay
New renal replacement therapy up to intensive care unit discharge, an average of 15 days proportion of patients needing renal replacement therapy
Limb ischaemia through short term mechanical circulatory support weaning, an average of 6 days proportion of patients with limb ischaemia
Short term mechanical circulatory support duration through short term mechanical circulatory support weaning, an average of 6 days Short term mechanical circulatory support duration
Severe haemorrage through short term mechanical circulatory support weaning, an average of 6 days proportion of patients with severe haemorrage (massive haemorrhage according to SFAR or use of Novoseven or rescue surgery for bleeding)
Extra Corporeal Membrane Oxygenation circuit clotting through short term mechanical circulatory support weaning, an average of 6 days proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured
Sepsis up to intensive care unit discharge, an average of 15 days proportion of patients in which sepsis occured
Trial Locations
- Locations (1)
Bordeaux University Hospital
🇫🇷Pessac, France