Menu
Recruiting NCT04389463

Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic

Observational Patients Undergoing Cardiac or Thoracic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Patients Undergoing Cardiac or Thoracic Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Other No intervention
    No description

Primary outcome measures

  • Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively. [Time frame: 12 hours post-operatively]
Secondary outcome measures (2)
  • Post-operative organ failure [Time frame: 5 days post-operatively]
  • Post-operative outcome [Time frame: 28 days post-operatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital — Nantes

Identifiers

NCT: NCT04389463 · HEART-19 Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗