NCT05752162

Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Carol Davila University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

A. Primary objective Identifying risk factors for peri-operative complications in patients who have had COVID-19. B. Secondary objectives Identifying peri-operative complications in patients who have had COVID-19. Follow-up of peri-operative complications during hospitalization. Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications. C. Study inclusion and exclusion criteria 1. Inclusion criteria Patients should be included if: * are scheduled for elective cardiac surgery with extracorporeal circulation (bypass); * they give their consent for their data to be included in studies; 2. Exclusion criteria Patients should be excluded if: * they have emergency surgery; * have had Sars Cov 2 infection more recently than 3 months; D. Data Collection It is done in an excel table. Data collection is done anonymously. No patient-identifying data will be collected. The collected data will be about comorbidities, COVID-19 status - disease and vaccination, postoperative complications.

Detailed description

Types of data collection from the patients: The type of surgery Age Sex Smoking Diabetes History of renal disease Preoperative anemia Preoperative creatinine Preoperative urea BMI NYHA class ASA score EuroScore I Preoperative LVEF Disease COVID -19 Date of illness Hospitalization for COVID-19 COVID 19 vaccination status Necessary vasopressor peri-operative duration and Maximum dose Perioperative positive inotrope required Bypass duration Duration of Aortic clamping Intraoperative transfusions Post operative creatinine - peak level Post-operative urea peak level Duration of post-operative oro-tracheal intubation NIV required Duration of hospitalization in Cardiac Intensive Care Unit Duration of postoperative hospitalization

Conditions

• Postoperative Complications
• COVID-19

Timeline

• Start date: 2022-07-20
• Primary completion: 2022-07-30
• Completion: 2025-06-30
• First posted: 2023-03-02
• Last updated: 2023-03-02

Locations

2 sites across 1 country: Romania