Patients Undergoing Cardiac or Thoracic SurgeryNCT04389463
Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic
An observational study of Patients Undergoing Cardiac or Thoracic Surgery, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Cardiac or Thoracic Surgery
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2020to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing cardiac or thoracic surgery during the COVID-19 pandemic.
Who may be able to join
- Adults (age ≥18 years) undergoing cardiac or thoracic surgery
- With positive PCR in the 5 days before or after cardiac/thoracic surgery.
Who cannot join
- Minors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Nantes, 44093
Mickael VOURC'H, MD, 0253482835, vourchm@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Keywords
- Cardiac surgery, Postoperative outcome, COVID-19, SARS-Cov 2 infection, Postoperative complication
- Medical subject headings
- COVID-19, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No description
| Study group | Role | What they receive |
|---|---|---|
| Cardiac or thoracic surgery in COVID-19 positive patients | Not described Receives: Other: No intervention | |
| Cardiac/thoracic surgery in COVID-19 negative patients | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours post-operatively
Secondary outcomes (2)
Post-operative organ failure
Prospective assessment of ICU outcomes until all included patients were discharged from ICU
Measured: 5 days post-operatively
Post-operative outcome
Prospective assessment of ICU outcomes until all included patients.
Measured: 28 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start11 May 2020
- Primary completion11 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Cardiac or Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389463
- Sponsor's protocol ID
- HEART-19 Study
- Status last verified
- Sep 2025
- First submitted
- 14 May 2020
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study
- ClinicalTrials.gov ID
- NCT04389463
- Acronym / sponsor ID
- HEART-19 Study
- Keywords
- Cardiac surgery, Postoperative outcome, COVID-19, SARS-Cov 2 infection, Postoperative complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac or thoracic surgery in COVID-19 positive patients | – | Other: No intervention |
| Cardiac/thoracic surgery in COVID-19 negative patients | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac or thoracic surgery during the COVID-19 pandemic.
Key inclusion criteria (2 listed)
- Adults (age ≥18 years) undergoing cardiac or thoracic surgery
- With positive PCR in the 5 days before or after cardiac/thoracic surgery.
Key exclusion criteria (1 listed)
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo description | Other | Cardiac or thoracic surgery in COVID-19 positive patients, Cardiac/thoracic surgery in COVID-19 negative patients |
Primary outcome
Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.
Time frame: 12 hours post-operatively
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.
2 secondary outcomes
Post-operative organ failure
Time frame: 5 days post-operatively
Post-operative outcome
Time frame: 28 days post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Cardiac or Thoracic Surgery, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mickael VOURC'H, MD (0253482835, vourchm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively. (time frame: 12 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.