Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
研究概览
简要总结
The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
- •Patient can sign informed consent before surgery.
- •Patient is able to comply with the study procedure.
- •Patient must require an indwelling radial or a femoral artery catheter.
- •Patient must be 20 years old or older.
- •Patient must be 40kg or heavier.
- •Patients height and weight can be accurately obtained prior to study start.
排除标准
- •Emergency surgery.
- •Patients with aortic or mitral valve regurgitation.
- •Renal insufficiency requiring hemodialysis.
- •Liver dysfunction (alanine/aspartate aminotransferase >40 U/L).
- •Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
- •Patient being treated with an intraaortic balloon pump.
- •Female patients with a known pregnancy.
- •Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
研究组 & 干预措施
2
干预措施: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine (Drug)
1
In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.
干预措施: Goal-directed hemodynamic therapy (Drug)
2
干预措施: Standard of care (Drug)
结局指标
主要结局
The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
时间窗: 6 month
次要结局
- Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)(6 month)