Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

Patients Undergoing Cardiac or Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389463
• Other study ID #: HEART-19 Study
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: Nantes University Hospital
• Contact: Mickael VOURC'H, MD
• Phone: 0253482835
• Email: vourchm[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2022
• Est. primary completion date: May 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Cardiac or Thoracic Surgery

Intervention

Other:
• No intervention
No description

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative organ failure	Prospective assessment of ICU outcomes until all included patients were discharged from ICU	5 days post-operatively
Secondary	Post-operative outcome	Prospective assessment of ICU outcomes until all included patients.	28 days post-operatively