Postoperative ComplicationsNCT05752162
Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
An observational study of Postoperative Complications and COVID-19, run by Carol Davila University of Medicine and Pharmacy at 2 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, COVID-19
- How many people
- 500 participants
- Where
- 2 sitesRomania
- Study dates
- 20 Jul 2022to 30 Jun 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients hospitalized in the Cardiac Intensive Care Unit 2 IUBCV CC Iliescu for postoperative management.
Who may be able to join
- are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
- they give their consent for their data to be included in studies;
Who cannot join
- they have emergency surgery;
- have had Sars Cov 2 infection more recently than 3 months;
Trial locations and contacts
2 sites in 1 country.
Romania2 sites, 2 recruiting
- Recruiting
IUBCV Prof. Dr. CC Iliescu
Bucharest
Cornelia Elena Predoi, cornelia.florescu@yahoo.ro
Cornelia Elena Predoi, phD student
- Recruiting
IUBCV Prof. Dr. CC Iliescu
Bucharest
Cornelia Elena Predoi
About this study
- Primary objective
Identifying risk factors for peri-operative complications in patients who have had COVID-19.
Read more
- 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.
- Study inclusion and exclusion criteria
- 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;
- Exclusion criteria
Patients should be excluded if:
- they have emergency surgery;
- have had Sars Cov 2 infection more recently than 3 months;
- 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.
Read the 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
- Conditions
- Postoperative Complications, COVID-19
- Medical subject headings
- Postoperative Complications, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying risk factors for peri-operative complications in patients who have had COVID-19
Measured: 3 years
Secondary outcomes (2)
Identifying peri-operative complications in patients who have had COVID-19
Follow-up of peri-operative complications during hospitalization.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Jul 2022
- Primary completion30 Jul 2022
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Elena Predoi, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752162
- Sponsor's protocol ID
- 20083/11.07.2022
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34793350Wajekar 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.
PubMed 34025062
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05752162
- Acronym / sponsor ID
- 20083/11.07.2022
- Conditions
- Postoperative Complications, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary objective
Identifying risk factors for peri-operative complications in patients who have had COVID-19.
- 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.
- Study inclusion and exclusion criteria
- 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;
- Exclusion criteria
Patients should be excluded if:
- they have emergency surgery;
- have had Sars Cov 2 infection more recently than 3 months;
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in the Cardiac Intensive Care Unit 2 IUBCV CC Iliescu for postoperative management.
Key inclusion criteria (2 listed)
- are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
- they give their consent for their data to be included in studies;
Key exclusion criteria (2 listed)
- they have emergency surgery;
- have had Sars Cov 2 infection more recently than 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying risk factors for peri-operative complications in patients who have had COVID-19
Time frame: 3 years
2 secondary outcomes
Identifying peri-operative complications in patients who have had COVID-19
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 34793350COVIDSurg 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.
- Results publication: PubMed 34025062Wajekar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and COVID-19, run by Carol Davila University of Medicine and Pharmacy at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelia Elena Predoi, phD student (+40736163107, cornelia.florescu@yahoo.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying risk factors for peri-operative complications in patients who have had COVID-19 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.