An observational study in Intra-Abdominal Hypertension and Postoperative Complications, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Observational
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This prospective observational study evaluated whether increased intra-abdominal pressure, meaning increased pressure inside the abdomen, is associated with postoperative complications and mortality in adults undergoing elective open-heart surgery with cardiopulmonary bypass. Intra-abdominal pressure was measured through the urinary bladder at three time points: after anesthesia induction, after closure of the sternum, and two hours after admission to the intensive care unit. Participants with an intra-abdominal pressure of 12 mmHg or higher at any measurement were compared with those whose pressure remained below 12 mmHg. The study examined postoperative recovery outcomes, including time to extubation, length of stay in the intensive care unit and hospital, postoperative complications, and mortality. It also aimed to identify perioperative factors associated with increased intra-abdominal pressure. No study-specific treatment or intervention was assigned, and all patients received standard perioperative care.
This prospective observational cohort study investigated perioperative changes in intra-abdominal pressure in patients undergoing elective open-heart surgery with cardiopulmonary bypass and examined whether increased intra-abdominal pressure was associated with postoperative recovery and adverse clinical outcomes.
Intra-abdominal pressure was assessed indirectly through urinary bladder pressure using a standardized measurement technique. Patients were placed in the supine position, 25 mL of sterile saline was instilled into the bladder, and pressure was recorded at end-expiration after zeroing the pressure transducer at the mid-axillary line. Measurements were obtained after induction of anesthesia, after sternal closure, and two hours after admission to the intensive care unit.
Intra-abdominal hypertension was defined as an intra-abdominal pressure of 12 mmHg or higher at any measurement time point. Patients meeting this definition were compared with patients whose intra-abdominal pressure remained below 12 mmHg at all measurements. Demographic, clinical, hemodynamic, laboratory, surgical, and postoperative data were collected prospectively.
No study-specific treatment or intervention was assigned. Anesthetic management, cardiopulmonary bypass management, fluid therapy, hemodynamic support, and postoperative care were provided according to routine institutional practice. The analyses were designed to evaluate associations between intra-abdominal hypertension and postoperative outcomes and to explore perioperative factors associated with increased intra-abdominal pressure. Because the study was observational, the findings were interpreted as associations rather than evidence of causality
71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.
This study's enrollment of 100 is close to the median of 98 across 36 observational studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consisted of consecutive adult patients scheduled for elective open-heart surgery with cardiopulmonary bypass at the Department of Anesthesiology and Reanimation of Bursa Yüksek İhtisas Training and Research Hospital between March 2023 and March 2024. Eligible patients who provided written informed consent were enrolled prospectively. Participants were classified according to whether intra-abdominal hypertension developed during the perioperative period. A total of 100 patients were enrolled, and 98 patients were included in the final comparative analysis.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IAH (+): Patients with an intra-abdominal pressure of ≥12 mmHg at least at one measurement time point.
IAH (-): Patients with an intra-abdominal pressure of\<12 mmHg at least at one measurement time point.
Number of Participants With Postoperative Complications
The number and percentage of participants who experienced each prespecified postoperative complication were assessed separately. Complications included arrhythmia, surgical-site infection, pneumonia, acute kidney injury, neurological complications, respiratory distress requiring continuous positive airway pressure, postoperative bleeding, reintubation, and prolonged mechanical ventilation. Outcomes were compared between participants with and without intra-abdominal hypertension.
Time frame: 1 year
In-Hospital All-Cause Mortality
The number and percentage of participants who died from any cause during the postoperative hospital stay were assessed and compared between participants with and without intra-abdominal hypertension.
Time frame: 1 year
Time to Extubation
Postoperative time from completion of surgery to removal of the endotracheal tube, recorded in hours and compared between participants with and without intra-abdominal hypertension.
Time frame: From completion of surgery to extubation
Intensive Care Unit Length of Stay
Duration of postoperative intensive care unit stay, recorded in hours and compared between participants with and without intra-abdominal hypertension.
Time frame: 4 weeks
Perioperative Factors Associated With Intra-Abdominal Hypertension
Associations between intra-abdominal hypertension and prespecified perioperative variables were evaluated. These variables included body mass index, cardiopulmonary bypass duration, aortic cross-clamp duration, fluid balance, central venous pressure, mean arterial pressure, heart rate, oxygen saturation, and blood lactate concentration.
Time frame: From preoperative assessment to 2 hours after intensive care unit admission
Plan to share: No — Individual participant data will not be shared because no prospective data-sharing plan or dedicated data repository was established for this study. Study findings will be reported in aggregate form in scientific publications
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Mar 2024, 12 months.
Of 20 observational studies under Intra-Abdominal Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 26. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Intra-Abdominal Hypertension →
Bursa Yuksek Ihtisas Training and Research Hospital