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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752162
• Other study ID #: 20083/11.07.2022
• Status: Recruiting
• Start date: July 20, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2023
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: Cornelia Elena Predoi, phD student
• Phone: +40736163107
• Email: cornelia.florescu[@]yahoo.ro
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19
• Postoperative Complications

Locations

Country	Name	City	State
Romania	IUBCV Prof. Dr. CC Iliescu	Bucharest
Romania	IUBCV Prof. Dr. CC Iliescu	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (2)

COVIDSurg Collaborative. Outcomes and Their State-level Variation in Patients Undergoing Surgery With Perioperative SARS-CoV-2 Infection in the USA: A Prospective Multicenter Study. Ann Surg. 2022 Feb 1;275(2):247-251. doi: 10.1097/SLA.0000000000005310. — View Citation

Wajekar AS, Solanki SL, Divatia JV. Pre-Anesthesia Re-Evaluation in Post COVID-19 Patients Posted for Elective Surgeries: an Online, Cross-Sectional Survey. Indian J Surg Oncol. 2021 Dec;12(Suppl 2):234-239. doi: 10.1007/s13193-021-01347-z. Epub 2021 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying risk factors for peri-operative complications in patients who have had COVID-19		3 years
Secondary	Identifying peri-operative complications in patients who have had COVID-19	Follow-up of peri-operative complications during hospitalization.	3 years
Secondary	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