Clinical trial NCT05752162: Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
Official title: Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
COVID-19
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the Cardiac Intensive Care Unit 2 IUBCV CC Iliescu for postoperative management.

Brief 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.

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

Eligibility criteria: 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;

Primary outcomes:
measure: Identifying risk factors for peri-operative complications in patients who have had COVID-19
timeFrame: 3 years
Secondary outcomes:
measure: Identifying peri-operative complications in patients who have had COVID-19
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: IUBCV Prof. Dr. CC Iliescu
city: Bucharest
country: Romania
facility: IUBCV Prof. Dr. CC Iliescu
Study officials:
References:
citation: 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.
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 17.