Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

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

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.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Cardiac or Thoracic Surgery
• Intervention / Treatment: Other: No intervention

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

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Mickael VOURC'H, MD; Phone Number: 0253482835; Email: vourchm@gmail.com
• Study Contact Backup: Name: Annick COULON; Phone Number: 0253482835; Email: bp-prom-regl@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • University Hospital
    • Contact: Mickael VOURC'H, MD; Phone Number: 0253482835; Email: vourchm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac or thoracic surgery in COVID-19 positive patients	Other: No intervention; No description
Cardiac/thoracic surgery in COVID-19 negative patients	Other: No intervention; No description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative organ failure	Prospective assessment of ICU outcomes until all included patients were discharged from ICU	5 days post-operatively
Post-operative outcome	Prospective assessment of ICU outcomes until all included patients.	28 days post-operatively

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): May 11, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Postoperative complication; Cardiac surgery; Postoperative outcome; SARS-Cov 2 infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HEART-19 Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No