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OpenTrials
Completed

NCT Number: NCT05412303

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pourcentage of death

    Time frame: Day 30

Secondary outcomes

  1. 1 - Number of complications

    Time frame: Day 30

    1- cardiac, neurological, renal, respiratory, red blood transfusion complication

  2. 2 - number of days in intensive care

    Time frame: through study completion, up to 15 days

  3. 3 - number of days in hospital

    Time frame: through study completion, up to 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ECMOVIS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.