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

C

Carol Davila University of Medicine and Pharmacy

Status

Enrolling

Conditions

COVID-19
Postoperative Complications

Study type

Observational

Funder types

Other

Identifiers

NCT05752162
20083/11.07.2022

Details and patient eligibility

About

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.

Full 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

Enrollment

500 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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;

Trial contacts and locations

1

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Central trial contact

Cornelia Elena Predoi, phD student

Data sourced from clinicaltrials.gov

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