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NCT Number: NCT04389463

Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery.

Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.

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Key information

About this study

Performing cardiac surgery in the context of SARS-CoV2 infection is potentially at risk of marked post-operative hemodynamic failure (shock) due to the inflammatory reaction generated by the surgery and the extracorporeal circulation associated with the viral infection. In addition, in the absence of infection, 30-50% of patients will experience acute post-operative respiratory failure due to the combined effects of extracorporeal circulation and general anesthesia. The pulmonary tropism of the virus therefore is susceptible to increase in post-operative respiratory impairment.

Thus, the infection is likely to favor the occurrence of post-operative shock but also to aggravate respiratory failure and other post-operative organ failures.

Therefore, the investigators designed an observational study that aims at comparing two groups of patients:

  • Cardiac or thoracic surgery patients with a negative Covid-19 PCR pre-operatively and in the 15 following days
  • Cardiac or thoracic surgery patients with a positive Covid-19 PCR in the 15 days before surgery

Who can participate

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

Inclusion criteria

  • Adults (age ≥18 years) undergoing cardiac or thoracic surgery
  • With positive PCR in the 5 days before or after cardiac/thoracic surgery.

Exclusion criteria

  • Minors

Treatment and study plan

No intervention

Other

No description

Primary outcomes

  1. Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.

    Time frame: 12 hours post-operatively

    The VIS score correlates with mortality after cardiac surgery and reflects the degree of patient hemodynamic failure. This score is calculated as follows:

    ISR = Dobutamine dose in g/kg/min + 100 times the Adrenaline dose in g/kg/min + 100 times the Noradrenaline dose in g/kg/min + 10,000 times the Vasopressin dose in U/kg/min.

Secondary outcomes

  1. Post-operative organ failure

    Time frame: 5 days post-operatively

    Prospective assessment of ICU outcomes until all included patients were discharged from ICU

  2. Post-operative outcome

    Time frame: 28 days post-operatively

    Prospective assessment of ICU outcomes until all included patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Annick COULON

CONTACT

[email protected]

0253482835

Mickael VOURC'H, MD

CONTACT

[email protected]

0253482835

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 15, 2020
Registry last updated
Sep 8, 2025

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.

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