The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Complications
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Number of Participants With Postoperative Complications
时间窗: 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.
In-Hospital All-Cause Mortality
时间窗: 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.
次要结局
- Time to Extubation(From completion of surgery to extubation)
- Intensive Care Unit Length of Stay(4 weeks)
研究者
Ilkay Ceylan
Associate proffesor
Bursa Yuksek Ihtisas Training and Research Hospital