Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

• Conditions: Patients Undergoing Cardiac or Thoracic Surgery
• Interventions: Other: No intervention

• Registration Number: NCT04389463
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-11
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20
• Primary Completion: 2022-05-11
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac or thoracic surgery in COVID-19 positive patients	No intervention	-
Cardiac/thoracic surgery in COVID-19 negative patients	No intervention	-

Primary Outcome Measures

Name	Time	Method
Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.	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 Outcome Measures

Name	Time	Method
Post-operative organ failure	5 days post-operatively	Prospective assessment of ICU outcomes until all included patients were discharged from ICU
Post-operative outcome	28 days post-operatively	Prospective assessment of ICU outcomes until all included patients.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France