Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

NCT ID: NCT04389463

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2026-06-30

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

Conditions

Patients Undergoing Cardiac or Thoracic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac or thoracic surgery in COVID-19 positive patients

No intervention

Intervention Type: OTHER

No description

Cardiac/thoracic surgery in COVID-19 negative patients

No intervention

Intervention Type: OTHER

No description

Interventions

No intervention

No description

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mickael VOURC'H, MD

Role: CONTACT

vourchm@gmail.com

0253482835

Annick COULON

Role: CONTACT

bp-prom-regl@chu-nantes.fr

0253482835

Facility Contacts

Mickael VOURC'H, MD

Role: primary

vourchm@gmail.com

0253482835

Other Identifiers

HEART-19 Study

Identifier Type: -

Identifier Source: org_study_id