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临床试验/NCT01091961
NCT01091961已完成不适用

Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Mean arterial blood pressure

研究概览

简要总结

Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.

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
Double (Investigator, Outcomes Assessor)

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

  • currently taking an ACEi, ARB or both
  • no change in these medications during the two weeks prior to study enrollment
  • scheduled for non-cardiac surgery requiring regional or general anesthesia
  • minimum overnight anticipated length of stay
  • age ≥18 years.

排除标准

  • explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
  • significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
  • significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)
  • prior enrollment in the study
  • participation in another research study of antihypertensive medications

结局指标

主要结局

Mean arterial blood pressure

时间窗: 24 hours after surgery

次要结局

  • Clinically significant hypertension(30 days after surgery)
  • Clinically significant hypotension(30 days after surgery)
  • All-cause mortality(30 days after surgery)
  • Cardiovascular morbidity(30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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