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

NCT ID: NCT05412303

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2769 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

EMCO-VA

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

With ECMO-VA

postcardiotomy cardiogenic shosck supported by ECMO-VA

data collection

Intervention Type: OTHER

age, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital

Without ECMO-VA

Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)

data collection

Intervention Type: OTHER

age, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital

Interventions

data collection

age, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

GUINOT 2022

Identifier Type: -

Identifier Source: org_study_id