Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

NCT04389463 | Recruiting

• 1 other identifier: HEART-19 Study
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Cardiac or Thoracic Surgery

Keywords

Cardiac surgery; Postoperative outcome; COVID-19; SARS-Cov 2 infection; Postoperative complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post-operative organ failure

  5 days post-operatively

• Post-operative outcome

  28 days post-operatively

Study Arms (2)

Cardiac or thoracic surgery in COVID-19 positive patients

Other: No intervention

Cardiac/thoracic surgery in COVID-19 negative patients

Other: No intervention

Interventions

No intervention OTHER

No description

Cardiac or thoracic surgery in COVID-19 positive patients; Cardiac/thoracic surgery in COVID-19 negative patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac or thoracic surgery during the COVID-19 pandemic.

You may qualify if:

• Adults (age ≥18 years) undergoing cardiac or thoracic surgery
• With positive PCR in the 5 days before or after cardiac/thoracic surgery.

You may not qualify if:

• Minors

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mickael VOURC'H, MD

CONTACT

0253482835; vourchm@gmail.com

Annick COULON

CONTACT

0253482835; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 15, 2020
• Study Start: May 11, 2020
• Primary Completion: May 11, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)