Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Corelation of endotoxin activity level with post-operative infectious complication
研究概览
简要总结
The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adults that is able to consent (≥ 18 years of age)
- •Scheduled to undergo PCNL at Uhealth tower and Jackson Memorial Hospitals
- •not currently immunosuppressed [White blood count (WBC) >= 2, not on immunosuppressive medications]
排除标准
- •unable to consent and < 18 years of age
- •currently immunosuppressed (WBC < 2, not on immunosuppressive medications)
结局指标
主要结局
Corelation of endotoxin activity level with post-operative infectious complication
时间窗: up to 24 hours
infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.
Number of participants at each endotoxin activity level after surgery.
时间窗: Day 1 (within 30 minutes postoperative)
The endotoxin activity level assessed from blood samples will be categorized as low (\<0.40), intermediate (0.40-0.59) or high (≥0.60) endotoxin activity level. Analysis will be done via Endotoxin Activity Assay (EAA).
次要结局
未报告次要终点
研究者
Hemendra Shah
Associate Professor of clinical Urology
University of Miami