Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- relapsing peritonitis
研究概览
简要总结
Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD peritonitis. After inform consent, specimens of PD effluent will be collected on the day of initiating antibiotic treatment, every 5 days until the day of completing antibiotic treatment, and then 28 days later for the test of LPS level. All patients will be followed for one year after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least two of the followings:
- •abdominal pain or cloudy PD effluent;
- •leukocytosis in PD effluent (WBC > 100/ml); and
- •positive Gram-stain or culture from PD effluent
排除标准
- •mycobacterial peritonitis
- •obvious surgical problems and require laparotomy
结局指标
主要结局
relapsing peritonitis
时间窗: 1 month
Relapsing peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode with the same organism (or culture negative in the second episode).
recurrent peritonitis
时间窗: 1 month
Recurrent peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode but with a different organism.
repeat peritonitis
时间窗: 6 months
Repeat peritonitis will be defined as an episode that occurs more than 4 weeks after completion of therapy of a prior episode with the same organism.
conversion to long-term hemodialysis
时间窗: 6 months
次要结局
- peritonitis that requires hospitalization(6 months)
- catheter removal(6 months)
- death due to peritonitis(6 months)
- all cause mortality(6 months)
研究者
Cheuk-Chun SZETO
Professor
Chinese University of Hong Kong