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

Recruiting

• Conditions: Postoperative Complications; COVID-19

• Registration Number: NCT05752162
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief 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

Study Timeline

• Study Start: 2022-07-20
• Primary Completion: 2022-07-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
• they give their consent for their data to be included in studies;

Exclusion Criteria

• they have emergency surgery;
• have had Sars Cov 2 infection more recently than 3 months;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifying risk factors for peri-operative complications in patients who have had COVID-19	3 years

Secondary Outcome Measures

Name	Time	Method
Identifying peri-operative complications in patients who have had COVID-19	3 years	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.	3 years

Trial Locations

Locations (1)

IUBCV Prof. Dr. CC Iliescu; 🇷🇴 Bucharest, Romania