跳至主要内容
临床试验/NCT01866787
NCT01866787Unknown不适用

Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change in baroreceptor function from preoperatively to 6 hours after surgery

研究概览

简要总结

The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.

The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.

详细描述

Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.

This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.

The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Scheduled for unilateral hip arthroplasty
  • 18 years or older
  • Able to give informed consent

排除标准

  • American Society of Anesthesiologists (ASA) class 3 or higher
  • Chronic arrythmia (Atrial fibrillation or other arrythmia)
  • Incompensated ischaemic heart disease
  • Mobilization restriction due to surgical reasons
  • Medical complications during admission requiring transferral to other department

结局指标

主要结局

Change in baroreceptor function from preoperatively to 6 hours after surgery

时间窗: 6 hours after surgery

Change in baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment before and 6 hours after surgery.

次要结局

  • Orthostatic Hypotension(Preoperative, 6 and 24 hours postoperative.)
  • Orthostatic response in blood pressure(Preoperative, 6 and 24 hours after surgery)
  • Inflammatory markers(preoperative, 6 and 24 hours postoperative)
  • Orthostatic response in heart rate variability(preoperative, 6 and 24 hours postoperative)
  • Orthostatic intolerance(preoperative, 6 and 24 hours after surgery)
  • Baroreceptor function(On the day of surgery: preoperatively, 6- and 24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oeivind Jans

M.D., Research Fellow

Rigshospitalet, Denmark

研究点 (1)

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