Coronary Artery DiseaseNCT07711951
CPB and Aortic Cross-Clamp Durations and ICU Length of Stay After CABG Retrospective Observational Cohort Study
An observational study of Coronary Artery Disease, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiopulmonary Bypass Duration and Aortic Cross-Clamp Duration
- How many people
- 387 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 21 Aug 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients who underwent elective isolated coronary artery bypass graft surgery at a single tertiary care center between January 1, 2019, and December 31, 2025. All patients meeting the predefined eligibility criteria and with complete electronic medical records required for the study analyses will be included in the retrospective cohort.
Who may be able to join
- 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
Who cannot join
- Emergency coronary artery bypass graft surgery
- Concomitant valve surgery
- Concomitant aortic surgery
- Reoperation cases
- Incomplete study-related data
- Intraoperative death
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatma Acil
Diyarbakır, Outside of the US, 21070
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiopulmonary Bypass Duration, Aortic Cross-Clamp Duration
- Keywords
- Cardiac Surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Bypass DurationOther
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 DurationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiopulmonary Bypass Duration; Other: Aortic Cross-Clamp Duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Intensive Care Unit Length of Stay
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.
Measured: Up to 30 days after surgery
Secondary outcomes (4)
Postoperative Atrial Fibrillation
Occurrence of new-onset atrial fibrillation during the postoperative period, identified from electrocardiographic findings and clinical records.
Measured: Up to 30 days after surgery
Acute Kidney Injury
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.
Measured: Up to 30 days after surgery
Postoperative Respiratory Failure
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.
Measured: Up to 30 days after surgery
30-Day All-Cause Mortality
Death from any cause occurring within 30 days after surgery.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start20 Jul 2026
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711951
- Sponsor's protocol ID
- 05.06.2026-276
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anastasiadis K, Antonitsis P, Voucharas C, Apostolidou-Kiouti F, Deliopoulos A, Haidich AB, Argiriadou H. Minimal invasive extracorporeal circulation versus conventional cardiopulmonary bypass in cardiac surgery: a contemporary systematic review and meta-analysis. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf112. doi: 10.1093/ejcts/ezaf112.
PubMed 40131383
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07711951
- Acronym / sponsor ID
- 05.06.2026-276
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 17 Jul 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Isolated CABG Cohort | – | Other: Cardiopulmonary Bypass Duration, Other: Aortic Cross-Clamp DurationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent elective isolated coronary artery bypass graft surgery at a single tertiary care center between January 1, 2019, and December 31, 2025. All patients meeting the predefined eligibility criteria and with complete electronic medical records required for the study analyses will be included in the retrospective cohort.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Emergency coronary artery bypass graft surgery
- Concomitant valve surgery
- Concomitant aortic surgery
- Reoperation cases
- Incomplete study-related data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Bypass DurationCardiopulmonary 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. | Other | Elective Isolated CABG Cohort |
| Aortic Cross-Clamp DurationAortic 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. | Other | Elective Isolated CABG Cohort |
Primary outcome
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.
4 secondary outcomes
Postoperative Atrial Fibrillation
Time frame: Up to 30 days after surgery
Acute Kidney Injury
Time frame: Up to 30 days after surgery
Postoperative Respiratory Failure
Time frame: Up to 30 days after surgery
30-Day All-Cause Mortality
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 40131383Anastasiadis K, Antonitsis P, Voucharas C, Apostolidou-Kiouti F, Deliopoulos A, Haidich AB, Argiriadou H. Minimal invasive extracorporeal circulation versus conventional cardiopulmonary bypass in cardiac surgery: a contemporary systematic review and meta-analysis. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf112. doi: 10.1093/ejcts/ezaf112.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Fatma Acil, M.D. principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Intensive Care Unit Length of Stay (time frame: Up to 30 days after surgery). 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 NCT07711951, which also lists 1 linked publication.
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 Sep 2026.