Fatma Acil
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07711951
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: Within 30 days after surgery
Death from any cause occurring within 30 days after surgery.
Contact information is provided by the study sponsor or research team.
Andaç Dedeoğlu, M.D.
CONTACT
Fatma Acil, M.D.
CONTACT
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07190690
Arterial Occlusive Diseases, Arteriosclerosis
Alicante, Spain
View Trial DetailsNCT05611307
ASCVD, Arterial Occlusive Diseases
Indianapolis, Indiana, United States
View Trial DetailsNCT06779630
Arterial Occlusive Diseases, Arteriosclerosis
Concord, California, United States
View Trial DetailsNCT07258290
Acute Coronary Syndrome, Angina Pectoris
Washington D.C., District of Columbia, United States
View Trial Details