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临床试验/NCT03392480
NCT03392480撤回不适用

Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery

Sun Yat-sen University8 个研究点 分布在 1 个国家开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
8
主要终点
Postoperative delirium duration

研究概览

简要总结

Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
  • No psychological and psychiatric history and presentation before surgery
  • No major organ dysfunction or failure

排除标准

  • Anemia (hemoglobin < 100 g/l) preoperatively.
  • Requires > 4 units of allogeneic red blood cell transfusion during the surgery
  • Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.
  • Can not cooperate with the study
  • History of bleeding
  • BMI < 18 or > 30
  • History of hemoglobin metabolism disorder

结局指标

主要结局

Postoperative delirium duration

时间窗: From day 0 to up to 7 days after the surgery

The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.

Postoperative delirium incidence

时间窗: From day 0 to up to 7 days after the surgery

The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.

次要结局

  • Oxidative stress level(Day 0 to day 2 after the surgery)
  • Inflammation level(Day 0 to day 2 after the surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiyi Zuo

Visiting Professor

Sun Yat-sen University

研究点 (8)

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