Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in immunity factor CXCL9 from 0 to 3 months
研究概览
简要总结
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection
详细描述
Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 weeks or more after total knee arthroplasty
- •One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
- •WBC count of aspirate >50,000 cells per μL
排除标准
- •Not willing to undergo blood draw at 3 months.
研究组 & 干预措施
PCA administraton
干预措施: Oral PCA (Dietary Supplement)
结局指标
主要结局
Change in immunity factor CXCL9 from 0 to 3 months
时间窗: 0 and 3 months
Change in HbA1c from 0 to 3 months
时间窗: 0 and 3 months
次要结局
- Reinfection rate after revision for prosthetic joint infection(0 to 4 years)
研究者
Dr. Dean Reeves
Primary Investigator
Dr. Dean Reeves Clinic