Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Number of Participants With Mild Hypotension
研究概览
简要总结
The purpose of this study is to determine the effects of Angiotension Converting Enzyme Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients undergoing elective total hip or knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients electing to undergo primary or revision total hip or knee arthroplasty
- •Currently taking an ACE-I
排除标准
- •Trauma patients
- •Immunosuppressed patients (HIV/AIDS, organ transplant recipients, chemotherapy patients, chronic steroid use)
- •Patients with history of severe hypertension related illness such as hypertension associated with stroke or myocardial infarction
- •Patients in who continuation of their ACE-I is expressly mandated by their prescribing physician
研究组 & 干预措施
Continuation Group
Subjects randomized to this group will continue their ACE-I through the day of surgery
干预措施: ACE-I Continuation group (Drug)
Cessation Group
Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)
干预措施: ACE-I Cessation group (Drug)
结局指标
主要结局
Number of Participants With Mild Hypotension
时间窗: From baseline to discharge from hospital (approximately 5 days)
The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.
Number of Participants With Severe Hypotension
时间窗: From baseline to discharge from hospital (approximately 5 days)
The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.
Number of Participants Given Vasopressors
时间窗: Discharge from hospital (approximately 5 days)
The number of participants who received vasopressors.
次要结局
- Number of Participants Transferred to Intensive Care Unit (ICU)(Discharge from hospital (approximately 5 days))
- Number of Participants That Received Allogeneic Blood(Discharge from hospital (approximately 5 days))
- Number of Participants With Acute Kidney Injury(Discharge from hospital (approximately 5 days))