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

Completed

• Conditions: EMCO-VA
• Interventions: Other: data collection

• Registration Number: NCT05412303
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2769

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without ECMO-VA	data collection	Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)
With ECMO-VA	data collection	postcardiotomy cardiogenic shosck supported by ECMO-VA

Primary Outcome Measures

Name	Time	Method
Pourcentage of death	Day 30

Secondary Outcome Measures

Name	Time	Method
1 - Number of complications	Day 30	1- cardiac, neurological, renal, respiratory, red blood transfusion complication
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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France