EUCTR2016-004141-90-GB进行中（未招募）1 期
Stopping Perioperative Angiotensin II Converting Enzyme inhibitors and/or receptor blockers in major non-cardiac surgery (SPACE): a phase II, explanatory, randomised controlled trial. - SPACE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Informed consent (no incapacitated or vulnerable adult or minors will be included).
- •Age 60 years and over.
- •Undergoing major surgery (major joint replacement/ vascular/ gastrointestinal) requiring general and/or regional anaesthesia with sedation.
- •Currently taking ACE-I, ARB or combined ACE-I and ARB therapy.
- •Duration of surgery longer than 120 minutes.
- •ASA grade 3 or above.
- •All female subjects must be postmenopausal, as demonstrated by clinical history or demonstrated not to be pregnant though a preoperative pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Current participation in any other trials where care or treatment is being altered.
- •Recent myocardial infarction (within 3 months).
- •Any condition, which in the opinion of the treating clinician would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.
研究者
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