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Completed
NCT07752082
The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery
Conditions: Intra-Abdominal Hypertension, Postoperative Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital
Location: Bursa Yuksek Ihtisas Research and Education Hospital Bursa Yıldırım
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Scheduled for elective open-heart surgery using cardiopulmonary bypass
* Left ventricular ejection fraction of 40% or higher
* Provision of written informed consent
Exclusion Criteria:
* Age under 18 years
* Requirement for emergency cardiac surgery
* Open-heart surgery performed without cardiopulmonary bypass
* Body mass index of 35 kg/m² or higher
* Uncontrolled diabetes mellitus
* History of urinary bladder or urinary tract surgery
* Active urinary tract infection
* Acute or chronic renal failure
* Neurogenic bladder
* History or presence of cerebrovascular disease
Source: ClinicalTrials.gov (NCT07752082). StuddyBuddy aggregates publicly available trial information.