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

NCT07752082 | Completed

• 1 other identifier: 2011-KAEK-25 2023/02-12
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-Abdominal Hypertension; Postoperative Complications

Keywords

Intra-abdominal pressure; intra-abdominal hypertension; morbidity and mortality; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 year

Secondary Outcomes (2)

• Time to Extubation

  From completion of surgery to extubation

• Intensive Care Unit Length of Stay

  4 weeks

Other Outcomes (1)

• Perioperative Factors Associated With Intra-Abdominal Hypertension

  From preoperative assessment to 2 hours after intensive care unit admission

Study Arms (2)

Intra-abdominal Hypertension Group

IAH (+): Patients with an intra-abdominal pressure of ≥12 mmHg at least at one measurement time point.

No Intra-abdominal Hypertension Group

IAH (-): Patients with an intra-abdominal pressure of\<12 mmHg at least at one measurement time point.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Yıldırım, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Postoperative Complications

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 7, 2026
• Study Start: March 2, 2023
• Primary Completion: March 2, 2024
• Study Completion: March 10, 2024
• Last Updated: August 7, 2026

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)