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NCT Number: NCT07752082

The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Yıldırım, 16310, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Postoperative Complications

    Time frame: 1 year

    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.

  2. In-Hospital All-Cause Mortality

    Time frame: 1 year

    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.

Secondary outcomes

  1. Time to Extubation

    Time frame: From completion of surgery 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.

  2. Intensive Care Unit Length of Stay

    Time frame: 4 weeks

    Duration of postoperative intensive care unit stay, recorded in hours and compared between participants with and without intra-abdominal hypertension.

Other outcomes

  1. Perioperative Factors Associated With Intra-Abdominal Hypertension

    Time frame: From preoperative assessment to 2 hours after intensive care unit admission

    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.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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.

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