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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT05412303

Collaborator

(none)

2,769

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
EMCO-VA	Other: data collection

Study Design

Study Type:

Observational

Actual Enrollment :

2769 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
With ECMO-VA postcardiotomy cardiogenic shosck supported by ECMO-VA	Other: 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
Without ECMO-VA Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)	Other: 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

Arm

Intervention/Treatment

With ECMO-VA

postcardiotomy cardiogenic shosck supported by ECMO-VA

Other: 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

Without ECMO-VA

Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)

Other: data collection

Outcome Measures

Primary Outcome Measures

Pourcentage of death [Day 30]

Secondary Outcome Measures

1 - Number of complications [Day 30]
1- cardiac, neurological, renal, respiratory, red blood transfusion complication
2 - number of days in intensive care [through study completion, up to 15 days]
3 - number of days in hospital [through study completion, up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT05412303

Other Study ID Numbers:

GUINOT 2022

First Posted:

Jun 9, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Cardiogenic

Study Results

No Results Posted as of Jun 9, 2022