Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team

Cardiogenic Shock Clinical Trial

— CASHMERE  

Official title:

Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309980
• Other study ID #: CHUBX2020RE0273
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 15, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Other:
• standard of care
retrospective study : standard of care

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital status	Proportion of patients alive	One year after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive	30 days after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive	3 months after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive	6 months after short term mechanical circulatory support initiation
Secondary	Lenght of stay	Intensive Care Unit length of stay	up to Intensive Care Unit discharge, an average of 15 days
Secondary	Lenght of stay	Hospital length of stay	up to one year
Secondary	Long term mechanical circulatory support	proportion of patients bridged to long term mechanical circulatory support	up to intensive care unit discharge, an average of 15 days
Secondary	Heart transplantation	proportion of patients bridged to heart transplantation	up to intensive care unit discharge, an average of 15 days
Secondary	Weaning from short term mechanical circulatory support	proportion of patients sucessfully weaned from short term mechanical circulatory support	up to seven days from weaning attempt
Secondary	New renal replacement therapy	proportion of patients needing renal replacement therapy	up to intensive care unit discharge, an average of 15 days
Secondary	Limb ischaemia	proportion of patients with limb ischaemia	through short term mechanical circulatory support weaning, an average of 6 days
Secondary	Stroke	proportion of patients with stroke	through short term mechanical circulatory support weaning, an average of 6 days
Secondary	Short term mechanical circulatory support duration	Short term mechanical circulatory support duration	through short term mechanical circulatory support weaning, an average of 6 days
Secondary	Severe haemorrage	proportion of patients with severe haemorrage (massive haemorrhage according to SFAR or use of Novoseven or rescue surgery for bleeding)	through short term mechanical circulatory support weaning, an average of 6 days
Secondary	Extra Corporeal Membrane Oxygenation circuit clotting	proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured	through short term mechanical circulatory support weaning, an average of 6 days
Secondary	Sepsis	proportion of patients in which sepsis occured	up to intensive care unit discharge, an average of 15 days
Secondary	Vital status	proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted	One year after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted	30 days after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted	3 months after short term mechanical circulatory support initiation
Secondary	Vital status	proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted	6 months after short term mechanical circulatory support initiation