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Completed

NCT Number: NCT05309980

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

retrospective study : standard of care

Primary outcomes

  1. Vital status

    Time frame: One year after short term mechanical circulatory support initiation

    Proportion of patients alive

Secondary outcomes

  1. Vital status

    Time frame: 30 days after short term mechanical circulatory support initiation

    proportion of patients alive

  2. Vital status

    Time frame: 3 months after short term mechanical circulatory support initiation

    proportion of patients alive

  3. Vital status

    Time frame: 6 months after short term mechanical circulatory support initiation

    proportion of patients alive

  4. Lenght of stay

    Time frame: up to Intensive Care Unit discharge, an average of 15 days

    Intensive Care Unit length of stay

  5. Lenght of stay

    Time frame: up to one year

    Hospital length of stay

  6. Long term mechanical circulatory support

    Time frame: up to intensive care unit discharge, an average of 15 days

    proportion of patients bridged to long term mechanical circulatory support

  7. Heart transplantation

    Time frame: up to intensive care unit discharge, an average of 15 days

    proportion of patients bridged to heart transplantation

  8. Weaning from short term mechanical circulatory support

    Time frame: up to seven days from weaning attempt

    proportion of patients sucessfully weaned from short term mechanical circulatory support

  9. New renal replacement therapy

    Time frame: up to intensive care unit discharge, an average of 15 days

    proportion of patients needing renal replacement therapy

  10. Limb ischaemia

    Time frame: through short term mechanical circulatory support weaning, an average of 6 days

    proportion of patients with limb ischaemia

  11. Stroke

    Time frame: through short term mechanical circulatory support weaning, an average of 6 days

    proportion of patients with stroke

  12. Short term mechanical circulatory support duration

    Time frame: through short term mechanical circulatory support weaning, an average of 6 days

    Short term mechanical circulatory support duration

  13. Severe haemorrage

    Time frame: 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)

  14. Extra Corporeal Membrane Oxygenation circuit clotting

    Time frame: through short term mechanical circulatory support weaning, an average of 6 days

    proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured

  15. Sepsis

    Time frame: up to intensive care unit discharge, an average of 15 days

    proportion of patients in which sepsis occured

  16. Vital status

    Time frame: One year after short term mechanical circulatory support initiation

    proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted

  17. Vital status

    Time frame: 30 days after short term mechanical circulatory support initiation

    proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted

  18. Vital status

    Time frame: 3 months after short term mechanical circulatory support initiation

    proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted

  19. Vital status

    Time frame: 6 months after short term mechanical circulatory support initiation

    proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CASHMERE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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