Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
NCT ID: NCT05752162
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2022-07-20
2025-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* they give their consent for their data to be included in studies;
Exclusion Criteria
* have had Sars Cov 2 infection more recently than 3 months;
ALL
Yes
Sponsors
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Carol Davila University of Medicine and Pharmacy
OTHER
Responsible Party
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Cornelia Elena Predoi
phD student
Locations
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IUBCV Prof. Dr. CC Iliescu
Bucharest, , Romania
IUBCV Prof. Dr. CC Iliescu
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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Cornelia Elena Predoi
Role: primary
References
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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.
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 17.
Other Identifiers
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20083/11.07.2022
Identifier Type: -
Identifier Source: org_study_id
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