- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711951
CPB and Aortic Cross-Clamp Durations and ICU Length of Stay After CABG Retrospective Observational Cohort Study
Association of Cardiopulmonary Bypass and Aortic Cross-Clamp Durations With Intensive Care Unit Length of Stay in Elective Isolated Coronary Artery Bypass Graft Surgery: A Retrospective Observational Cohort Study
Cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC) durations are important intraoperative factors that may influence postoperative recovery following coronary artery bypass graft (CABG) surgery. Prolonged CPB and ACC durations may be associated with increased postoperative morbidity and extended intensive care unit (ICU) stay.
This retrospective observational cohort study aims to evaluate the independent associations of CPB and ACC durations with postoperative ICU length of stay in adult patients undergoing elective isolated CABG surgery. Electronic medical records of eligible patients who underwent surgery between January 1, 2019, and December 31, 2025, at a single tertiary care center will be retrospectively reviewed. Multivariable regression analyses will be performed to assess these associations after adjustment for clinically relevant potential confounders.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC) are essential components of coronary artery bypass graft (CABG) surgery. Prolonged CPB and ACC durations may contribute to systemic inflammatory responses, alterations in organ perfusion, and postoperative morbidity, potentially resulting in delayed postoperative recovery and prolonged intensive care unit (ICU) stay.
This single-center retrospective observational cohort study is designed to investigate the association of CPB and ACC durations with postoperative ICU length of stay in adult patients undergoing elective isolated CABG surgery. The electronic medical records of patients who underwent elective isolated CABG surgery between January 1, 2019, and December 31, 2025, will be retrospectively reviewed.
Demographic and preoperative clinical characteristics, including age, sex, body mass index, left ventricular ejection fraction, diabetes mellitus, chronic obstructive pulmonary disease, and chronic kidney disease, will be collected. Intraoperative data will include operative duration, CPB duration, and ACC duration. Postoperative ICU length of stay will be defined as the time from postoperative ICU admission to transfer from the ICU to the hospital ward.
The primary outcome of the study is postoperative ICU length of stay. CPB and ACC durations will be evaluated as continuous exposure variables measured in minutes. Their independent associations with ICU length of stay will be assessed using separate multivariable regression models adjusted for clinically relevant potential confounders. The distribution of ICU length of stay will be evaluated before multivariable analysis. Depending on the distributional characteristics of the outcome, multivariable linear regression after appropriate transformation or a generalized linear model with an appropriate distribution and link function will be used.
The study involves retrospective analysis of routinely collected clinical data and does not include any additional intervention, diagnostic procedure, or treatment related to the research.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatma Acil, M.D.
- Phone Number: +905337225225
- Email: acilfatma@gmail.com
Study Contact Backup
- Name: Andaç Dedeoğlu, M.D.
- Phone Number: +905326848626
- Email: anderen77@hotmail.com
Study Locations
-
-
Outside of the US
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Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
- Recruiting
- Fatma Acil
-
Contact:
- Fatma Acil, M.D.
- Phone Number: 05337225225
- Email: acilfatma@gmail.com
-
Sub-Investigator:
- Andaç Dedeoğlu, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Underwent elective isolated coronary artery bypass graft surgery
- Surgery performed between January 1, 2019, and December 31, 2025
- Availability of complete electronic medical records required for the study analyses
Exclusion Criteria:
- Emergency coronary artery bypass graft surgery
- Concomitant valve surgery
- Concomitant aortic surgery
- Reoperation cases
- Incomplete study-related data
- Intraoperative death
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elective Isolated CABG Cohort
Adult patients who underwent elective isolated coronary artery bypass graft surgery between January 1, 2019, and December 31, 2025, and met the predefined eligibility criteria.
Cardiopulmonary bypass and aortic cross-clamp durations will be evaluated as continuous exposure variables.
|
Cardiopulmonary bypass duration, defined as the total duration of cardiopulmonary bypass during elective isolated coronary artery bypass graft surgery and recorded in minutes.
This exposure will be evaluated as a continuous variable based on routinely collected perfusion records.
Aortic cross-clamp duration, defined as the total duration of aortic cross-clamping during elective isolated coronary artery bypass graft surgery and recorded in minutes.
This exposure will be evaluated as a continuous variable based on routinely collected operative and perfusion records.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Intensive Care Unit Length of Stay
Time Frame: Up to 30 days after surgery
|
Postoperative intensive care unit length of stay will be defined as the duration from admission to the intensive care unit following surgery until transfer from the intensive care unit to the hospital ward and will be recorded in days.
Patients who die during the intensive care unit stay will not be included in the primary intensive care unit length-of-stay analysis.
|
Up to 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Atrial Fibrillation
Time Frame: Up to 30 days after surgery
|
Occurrence of new-onset atrial fibrillation during the postoperative period, identified from electrocardiographic findings and clinical records.
|
Up to 30 days after surgery
|
|
Acute Kidney Injury
Time Frame: Up to 30 days after surgery
|
Occurrence of postoperative acute kidney injury defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, or urine output <0.5 mL/kg/h for at least 6 hours.
|
Up to 30 days after surgery
|
|
Postoperative Respiratory Failure
Time Frame: Up to 30 days after surgery
|
Occurrence of postoperative respiratory failure, defined as the need for invasive mechanical ventilation for more than 48 hours after surgery, unplanned reintubation due to respiratory failure following initial extubation, or the need for noninvasive ventilatory support due to persistent or worsening respiratory failure during the postoperative period.
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Up to 30 days after surgery
|
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30-Day All-Cause Mortality
Time Frame: Within 30 days after surgery
|
Death from any cause occurring within 30 days after surgery.
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Within 30 days after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.06.2026-276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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