Recovery after heart or chest surgery during the COVID-19 pandemic
Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study
This study will see if adults having cardiac or thoracic surgery who recently had COVID-19 have more postoperative shock, breathing problems, or other organ failures than those without COVID.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT04389463 on ClinicalTrials.gov |
What this trial studies
This is an observational, non-interventional study at Nantes University Hospital enrolling adults undergoing cardiac or thoracic surgery. It compares patients with a positive SARS‑CoV‑2 PCR in the perioperative period to patients who are PCR-negative before surgery and during the 15 days after surgery, focusing on postoperative hemodynamic failure, respiratory failure, and other organ dysfunction. Data are collected from medical records only and no patient-identifiable information is stored. The goal is to capture real-world perioperative outcomes during the COVID-19 pandemic to help inform clinical management.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for cardiac or thoracic surgery who have perioperative SARS‑CoV‑2 PCR testing are the intended participants.
Not a fit: Minors and people not undergoing cardiac or thoracic surgery, or those without perioperative PCR testing, would not be eligible and are unlikely to benefit directly from this study.
Why it matters
Potential benefit: If successful, the results could help clinicians identify and better manage increased risk of postoperative shock, respiratory failure, and organ dysfunction in surgical patients with recent SARS‑CoV‑2 infection.
How similar studies have performed: Other observational reports have reported higher rates of postoperative pulmonary and thrombotic complications in patients with perioperative SARS‑CoV‑2, but findings are variable and high-quality prospective data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- University Hospital — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Mickael VOURC'H, MD
- Email: vourchm@gmail.com
- Phone: 0253482835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.