Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Total Blood Volume
研究概览
简要总结
Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.
The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.
Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels
详细描述
Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non- inflammatory degenerative joint disease of the hip
- •Patients scheduled for unilateral primary total hip arthroplasty
- •Age between 50 and 75 years
- •Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP <
- •Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery
排除标准
- •Pregnant women or nursing mothers.
- •Women of childbearing potential not using adequate birth control methods
- •Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
- •Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- •Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
- •Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
- •Congestive Heart Failure (at least one medication to treat congestive heart failure)
- •Coronary artery disease (s/p bypass, stent or AMI)
- •Kidney insufficiency (creatinine > 1.5)
- •Aortic or mitral valve disease
- •Pulmonary hypertension
- •Revision Hip Surgery
- •Inadequate intravenous fluid substitution within the first 6 hrs (<3 liters)
- •Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
结局指标
主要结局
Change in Total Blood Volume
时间窗: preoperatively and 6 hours postoperatively
The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.
次要结局
未报告次要终点