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Clinical Trials/NCT05412303
NCT05412303CompletedNot Applicable

Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.

Centre Hospitalier Universitaire Dijon2 sites in 1 country2,769 target enrollmentStarted: January 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,769
Locations
2
Primary Endpoint
Pourcentage of death

Study Overview

Brief Summary

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.

Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age over 18 years
  • Cardiac surgery with cardiopulmonary bypass
  • Post cardiotomy cardiogenic shock
  • ECMO-VA implanted in OR

Exclusion Criteria

  • Heart transplantation
  • Incomplete data in relation to outcomes
  • Cardiac arrest

Outcomes

Primary Outcomes

Pourcentage of death

Time Frame: Day 30

Secondary Outcomes

  • 1 - Number of complications(Day 30)
  • 3 - number of days in hospital(through study completion, up to 3 months)
  • 2 - number of days in intensive care(through study completion, up to 15 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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