Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Patients Undergoing Cardiac or Thoracic Surgery

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac or thoracic surgery in COVID-19 positive patients<br> | Other: No intervention<br>* No description<br>|
| Cardiac/thoracic surgery in COVID-19 negative patients<br> | Other: No intervention<br>* No description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively. | 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. | 12 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative organ failure | Prospective assessment of ICU outcomes until all included patients were discharged from ICU | 5 days post-operatively | 
| Post-operative outcome | Prospective assessment of ICU outcomes until all included patients. | 28 days post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Postoperative outcome, COVID-19, SARS-Cov 2 infection, Postoperative complication