Use of an Intraabdominal Pressure Monitoring Urinary Catheter After Cardiac Surgery to Improve Kidney Perfusion Pressure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria
研究概览
简要总结
The goal of this clinical trial is to determine whether monitoring intra-abdominal pressure (IAP) and adjusting blood pressure accordingly to maintain optimal renal perfusion pressure can reduce the risk of acute kidney injury (AKI) after cardiac surgery.
The main question this study aims to answer is:
- Does IAP-guided blood pressure management improve renal perfusion and lower AKI rates in cardiac surgery patients?
Participants will be randomly assigned to one of two groups:
- Control Group: Standard ICU care with a conventional Foley catheter.
- Intervention Group: Standard ICU care with an IAP-monitoring Foley catheter, where blood pressure is adjusted based on IAP readings to optimize renal perfusion pressure.
All participants will undergo routine blood and urine tests to assess kidney function during their hospital stay.
This study will help determine whether IAP-based hemodynamic management can improve postoperative kidney outcomes and provide a new strategy for AKI prevention in cardiac surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults Undergoing cardiac surgery with cardiopulmonary bypass
- •Left ventricular ejection fraction (LVEF) < 50%
排除标准
- •Current pregnancy
- •ESRD or AKI on dialysis
- •Currently on ECMO or Impella
- •Emergent surgery
研究组 & 干预措施
Intervention Group - IAP Monitoring and Renal Perfusion Pressure Optimization
Participants will receive standard ICU care after cardiac surgery with an IAP-monitoring Foley catheter. Blood pressure will be adjusted based on IAP readings to optimize renal perfusion pressure(41mmHg).
干预措施: Accuryn Foley Catheter (Device)
Control Group - Standard ICU Care with Conventional Foley
Participants will receive standard ICU care after cardiac surgery with a conventional Foley catheter. Blood pressure management will follow routine ICU protocols without intra-abdominal pressure (IAP) monitoring.
干预措施: Conventional Foley Catheter(Medline) (Device)
结局指标
主要结局
Incidence of Postoperative Acute Kidney Injury (AKI) as defined by KDIGO Criteria
时间窗: Perioperative.
Acute Kidney Injury will be defined using the KDIGO criteria: an increase in serum creatinine by ≥0.3 mg/dL within 48 hours or an increase to ≥1.5 times the baseline.
次要结局
- ICU Length of Stay(Perioperative)
- Hospital Length of Stay(Perioperative)
研究者
Dang Tan Phat
Assistant Clinical Professor, Department of Anesthesiology & Perioperative Care, University of California, Irvine
University of California, Irvine