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临床试验/NCT01817309
NCT01817309已完成4 期

Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2013年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheuk-Chun SZETO

Professor

Chinese University of Hong Kong

研究点 (1)

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