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临床试验/NCT07662577
NCT07662577已完成不适用

Effects of Two Different Mean Arterial Pressure Targets During Controlled Hypotension on Renal Injury Assessed by NGAL Levels in Patients Undergoing Septoplasty

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1

研究概览

简要总结

This prospective randomized single-blind study investigated the effects of two different mean arterial pressure (MAP) targets during controlled hypotension on renal injury in patients undergoing septoplasty. Participants were randomized to a low MAP target group (50-57 mmHg) or a higher MAP target group (58-65 mmHg). Renal injury was assessed using plasma neutrophil gelatinase-associated lipocalin (NGAL) levels measured at baseline, 6 hours, and 24 hours postoperatively.

详细描述

Controlled hypotension is frequently used during septoplasty to reduce intraoperative bleeding and improve surgical field visibility. However, excessive reductions in mean arterial pressure (MAP) may impair renal perfusion and potentially contribute to postoperative kidney injury. Traditional markers of renal dysfunction, such as serum creatinine, may not detect early renal injury. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a sensitive biomarker for the early detection of acute kidney injury.

This prospective randomized study was designed to evaluate the effects of two different MAP target ranges during controlled hypotension on renal injury in patients undergoing elective septoplasty under general anesthesia. Patients were randomly assigned to one of two groups: a lower MAP target group (50-57 mmHg) and a higher MAP target group (58-65 mmHg). Controlled hypotension was achieved according to standard anesthetic practice throughout surgery.

Renal injury was assessed by measuring plasma NGAL concentrations preoperatively and at predetermined postoperative time points. Additional renal function parameters, including serum creatinine levels, urine output, and acute kidney injury classifications, were evaluated. Intraoperative hemodynamic variables and renal regional oxygen saturation values were also recorded.

The primary objective of the study was to determine whether different levels of controlled hypotension influence early renal injury as assessed by NGAL measurements. Secondary objectives included evaluation of conventional renal function parameters, renal tissue oxygenation, and perioperative hemodynamic outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 65 years
  • Scheduled for elective septoplasty under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Planned controlled hypotension during surgery
  • Provided written informed consent

排除标准

  • Body mass index (BMI) > 35 kg/m²
  • History of hypertension
  • Diabetes mellitus
  • Coronary artery disease
  • Cerebrovascular disease
  • Carotid artery stenosis
  • Vertebrobasilar insufficiency
  • Pre-existing renal dysfunction
  • Hypovolemia
  • Refusal to participate in the study

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Nur Teke

medical doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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