Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Patients Undergoing Cardiac or Thoracic Surgery

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04389463

HEART-19 Study

Details and patient eligibility

About

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.

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

Cardiac or thoracic surgery in COVID-19 positive patients

Treatment:

Other: No intervention

Cardiac/thoracic surgery in COVID-19 negative patients

Treatment:

Other: No intervention