Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic
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 →
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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