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

February 28, 2023 updated by: Cornelia Elena Predoi, Carol Davila University of Medicine and Pharmacy

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Bucharest, Romania
        • Recruiting
        • IUBCV Prof. Dr. CC Iliescu
        • Contact:
          • Cornelia Elena Predoi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in the Cardiac Intensive Care Unit 2 IUBCV CC Iliescu for postoperative management.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identifying risk factors for peri-operative complications in patients who have had COVID-19
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying peri-operative complications in patients who have had COVID-19
Time Frame: 3 years
Follow-up of peri-operative complications during hospitalization.
3 years
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.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Davila University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Actual)

July 30, 2022

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20083/11.07.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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