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临床试验/NCT07603336
NCT07603336招募中不适用

Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Study

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This prospective randomized study aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing pancreaticoduodenectomy. Patients will be allocated to either mean arterial pressure-guided hemodynamic management or cardiac index-guided hemodynamic management during surgery.

Pancreaticoduodenectomy is a major abdominal surgical procedure associated with prolonged operative duration, considerable fluid shifts, blood loss, and hemodynamic instability. These factors may contribute to impaired renal perfusion and postoperative renal dysfunction. Although mean arterial pressure is commonly used to guide intraoperative hemodynamic management, blood pressure alone may not fully reflect systemic blood flow or 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 level from the preoperative baseline value to the postoperative 72nd hour. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, length of intensive care unit and hospital stay, and 30-day mortality.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 pancreaticoduodenectomy / Whipple procedure
  • Patients who provide written informed consent

排除标准

  • 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

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Atakan Sezgi

Principal Investigator

Ankara Etlik City Hospital

研究点 (1)

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