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
At least 18 years old Undergoing open-chest cardiac surgery With a history of SARS-CoV-2 infection Absence of respiratory infection-related symptoms or without the symptoms for more than 2 weeks Negative COVID-19 nucleic acid test result and without any sign of viral pneumonia based on a chest computed tomography (CT) scan on the day of randomization
Exclusion criteria
Emergent/urgent surgery, i.e., heart transplantation, surgeries for acute aortic dissection, et. al. Renal insufficiency with estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m2 Severe liver injury (Class C of Child-Pugh classification) Known allergy, intolerance, or contraindications to nirmatrelvir/ritonavir or ursodeoxycholic acid Having taken the following medications within the last 5 days (consideration for enrollment may be given if the patient's condition allows for a 5-day discontinuation period): alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, neratinib, venetoclax, amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine, fusidic acid, voriconazole, astemizole, tefenadine, colchicine, rifabutin, rifampicin, lurasidone, clozapine, pimozide, quetiapine, ergot derivatives, cisapride, clorazepate, lovastatin, simvastatin, lomitapide, avanafil, sildenafil, vardenafil, diazepam, sulazepam, flurazepam, midazolam triazolam, carbamazepine, phenobarbital, and phenytoin
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 Stroke | 30 days after surgery or during hospitalization | new onset of stroke |
| 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 Ventilation ≥24h | 30 days after surgery or during hospitalization | Ventilation ≥24h after surgery |
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShengshou Hu
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed