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

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.

Study Overview

• Status: Completed
• Conditions: Cardiogenic Shock; Short Term Mechanical Circulatory Support; Shock Team
• Intervention / Treatment: Other: standard of care

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Without Shock Team; Before January 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device without involvment of a dedicated shock team	Other: standard of care; retrospective study : standard of care
With Shock Team; 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.	Other: standard of care; retrospective study : standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital status	Proportion of patients alive	One year after short term mechanical circulatory support initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital status	proportion of patients alive	30 days after short term mechanical circulatory support initiation
Vital status	proportion of patients alive	3 months after short term mechanical circulatory support initiation
Vital status	proportion of patients alive	6 months after short term mechanical circulatory support initiation
Lenght of stay	Intensive Care Unit length of stay	up to Intensive Care Unit discharge, an average of 15 days
Lenght of stay	Hospital length of stay	up to one year
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
Heart transplantation	proportion of patients bridged to heart transplantation	up to intensive care unit discharge, an average of 15 days
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
New renal replacement therapy	proportion of patients needing renal replacement therapy	up to intensive care unit discharge, an average of 15 days
Limb ischaemia	proportion of patients with limb ischaemia	through short term mechanical circulatory support weaning, an average of 6 days
Stroke	proportion of patients with stroke	through short term mechanical circulatory support weaning, an average of 6 days
Short term mechanical circulatory support duration	Short term mechanical circulatory support duration	through short term mechanical circulatory support weaning, an average of 6 days
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
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
Sepsis	proportion of patients in which sepsis occured	up to intensive care unit discharge, an average of 15 days
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cardiogenic Shock; Impella; Extra Corporeal Membrane Oxygenation; Shock Team; Long Term Mechanical Circulatory Support
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: CHUBX2020RE0273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No