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

NCT05412303 | Completed

• 1 other identifier: GUINOT 2022
• Study Type: observational
• Target: 2,769
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pourcentage of death

  Day 30

Secondary Outcomes (3)

• 1 - Number of complications

  Day 30

• 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

Study Arms (2)

With ECMO-VA

postcardiotomy cardiogenic shosck supported by ECMO-VA

Other: data collection

Without ECMO-VA

Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)

Other: data collection

Interventions

data collection 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

With ECMO-VA; Without ECMO-VA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post cardiotomy cardiogenic shock

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 9, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-05

Locations

FR (1)