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

NCT ID: NCT05752162

Last Updated: 2023-03-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2025-06-30

Brief Summary

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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

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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

Conditions

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Postoperative Complications COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carol Davila University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Cornelia Elena Predoi

phD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IUBCV Prof. Dr. CC Iliescu

Bucharest, , Romania

Site Status RECRUITING

IUBCV Prof. Dr. CC Iliescu

Bucharest, , Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Cornelia Elena Predoi, phD student

Role: CONTACT

+40736163107

Facility Contacts

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Cornelia Elena Predoi

Role: primary

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.

Reference Type RESULT
PMID: 34793350 (View on PubMed)

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.

Reference Type RESULT
PMID: 34025062 (View on PubMed)

Other Identifiers

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20083/11.07.2022

Identifier Type: -

Identifier Source: org_study_id

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