MAP- Versus Cardiac Index-Guided Hemodynamic Management in Colorectal Surgery
Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Colorectal Surgery: A Prospective Randomized Study
This prospective randomized trial aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing colorectal surgery. Patients will be randomly assigned to receive either mean arterial pressure-guided or cardiac index-guided intraoperative hemodynamic management.
Colorectal surgery is a major abdominal procedure associated with prolonged operative times, significant fluid shifts, blood loss, and hemodynamic instability. These factors can contribute to impaired renal perfusion and subsequent postoperative renal dysfunction. Although mean arterial pressure is widely used to guide intraoperative hemodynamic management, blood pressure alone may not adequately reflect systemic blood flow or regional tissue perfusion. Cardiac index-guided management may provide a more direct assessment of global circulatory adequacy.
The primary outcome of the study is the change in serum creatinine levels from the preoperative baseline to 72 hours postoperatively. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, intensive care unit (ICU) and hospital length of stay, and 30-day mortality.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：İbrahim MD Topcu
- 电话号码：00905437860316
- 邮箱：ibrahimtpc78@gmail.com
研究联系人备份
- 姓名：Musa Ass. Prof Zengin
- 电话号码：00905307716235
- 邮箱：musazengin@gmail.com
学习地点
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Yenimahalle\Ankara
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Ankara、Yenimahalle\Ankara、土耳其（türkiye）、06170
- 招聘中
- Ankara Etlik City Hospital
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接触：
- İbrahim MD Topcu
- 电话号码：05437860316
- 邮箱：ibrahimtpc78@gmail.com
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接触：
- Musa Assoc.Prof Zengin
- 电话号码：00905307716235
- 邮箱：musazengin@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 18 to 80 years
- Patients with American Society of Anesthesiologists physical status II-III
- Patients with estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- Patients scheduled for colorectal surgery
- Patients who provide written informed consent
Exclusion Criteria:
- Patients younger than 18 years or older than 80 years
- Patients with estimated glomerular filtration rate <60 mL/min/1.73 m²
- Patients with American Society of Anesthesiologists physical status other than II-III
- Patients who refuse to participate in the study
- Patients who withdraw consent at any stage of the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Cardiac Index-Guided Hemodynamic Management
Patients in this group will receive intraoperative hemodynamic management based on predefined cardiac index targets.
Hemodynamic interventions, including fluid administration, vasopressor or inotrope therapy, and other standard intraoperative management strategies, will be guided primarily by cardiac index values.
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Intraoperative hemodynamic management will be performed according to predefined cardiac index targets during colorectal surgery.
Cardiac index values will be monitored intraoperatively, and fluid therapy, vasopressor use, and inotrope administration will be adjusted according to the hemodynamic status of the patient and institutional clinical practice.
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有源比较器：Mean Arterial Pressure-Guided Hemodynamic Management
Patients in this group will receive intraoperative hemodynamic management based on predefined mean arterial pressure targets.
Hemodynamic interventions, including fluid administration, vasopressor therapy, and other standard intraoperative management strategies, will be guided primarily by mean arterial pressure values
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Intraoperative hemodynamic management will be performed according to predefined mean arterial pressure targets during colorectal surgery.
Standard anesthetic care, fluid therapy, vasopressor use, and intraoperative monitoring will be applied according to institutional clinical practice.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum creatinine level from baseline to postoperative 72 hours
大体时间：: Preoperative baseline and postoperative 72nd hour
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The primary outcome is the change in serum creatinine level, calculated as the difference between the serum creatinine value measured at postoperative 72 hours and the preoperative baseline serum creatinine value.
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: Preoperative baseline and postoperative 72nd hour
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative urine output
大体时间：From anesthesia induction to the end of surgery
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Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.
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From anesthesia induction to the end of surgery
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Total intraoperative fluid administration
大体时间：From anesthesia induction to the end of surgery
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The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.
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From anesthesia induction to the end of surgery
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Postoperative serum creatinine levels
大体时间：Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period.
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Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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