Cardiac Surgery
Conditions
Brief summary
Prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. The aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.
Detailed description
After informed consent, four centers and 436 eligible admissions will be recruited. Eligible patients would be randomized (1:1:1:1) to nirmatrelvir/ritonavir group (nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days), ursodeoxycholic acid group (ursodeoxycholic acid group, 15mg/kg/day bid for5 days), combination group (nirmatrelvir/ritonavir and ursodeoxycholic acid for 5days) and control group.
Interventions
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
DRUGUrsodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * COVID-19 nucleic acid test or antigen test positive history, without symptom or recover from COVID-19 related symptoms ≥2 weeks * Receive open-chest cardiac surgery * COVID-19 nucleic acid test and antigen test negative and no signs of pneumonia in chest CT * Patients with written informed consent.
Exclusion criteria
* Emergency surgery * eGFR ≤30ml/min * Severe liver dysfunction * Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | 30 days after surgery or during hospitalization | All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days after surgery or during hospitalization | All-cause mortality |
| Rate of Myocardial infarction | 30 days after surgery or during hospitalization | new onset of myocardial infarction |
| Rate of Moderate to severe acute kidney injury | 30 days after surgery or during hospitalization | new onset of moderate to severe acute kidney injury |
| Rate of COVID-19 pneumonia | 30 days after surgery or during hospitalization | new onset of COVID-19 pneumonia |
| Rate of Cardiogenic death | 30 days after surgery or during hospitalization | Cardiogenic death |
| Rate of Severe pneumonia | 30 days after surgery or during hospitalization | new onset of Severe pneumonia |
| Rate of Stroke | 30 days after surgery or during hospitalization | new onset of stroke |
| Rate of Pulmonary embolism | 30 days after surgery or during hospitalization | new onset of Pulmonary embolism |
| Rate of Re-operation for bleeding | 30 days after surgery or during hospitalization | Re-operation for bleeding after primary surgery |
| Rate of Renal insufficiency | 1 year after surgery | new onset of Renal insufficiency |
| Rate of Re-hospitalization for respiratory disease | 1 year after surgery | Re-hospitalization for respiratory disease |
| Rate of Cardiogenic re-hospitalization | 1 year after surgery | Cardiogenic re-hospitalization |
| Rate of Ventilation ≥24h | 30 days after surgery or during hospitalization | Ventilation ≥24h after surgery |
Countries
China
Outcome results
None listed