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临床试验/NCT04594421
NCT04594421Unknown不适用

Study on the Increasing Proportion and Change Trend of Eosinophil in Peritoneal Fluid During Peritoneal Dialysis-Related Peritonitis

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Prevalence of elevated eosinophils in peritoneal dialysis effluent

研究概览

简要总结

A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. This study will provide evidence for routine eosinophil testing

详细描述

A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. In this study, 100 patients with peritoneal dialysis-associated peritonitis who meet the inclusion criteria will be selected. Demographic data, laboratory variables, peritoneal fluid cytology and bacterial culture will be collected within 24 hours of peritonitis (day 1). Peritoneal fluid cytology includes leukocyte classification and eosinophilic leukocyte count will be examined at day 3, 5, 7, 10, 14, 21, 30, 60 and 90 after peritonitis. All patients will be followed up for 90 days, and their peritonitis outcome will be recorded. The primary endpoint is the prevalence of eosinophil increase in peritoneal effluent, which is defined as >100 eosinophils/mm^3, or >10% eosinophils of the total non-erythrocyte count. Secondary end points are peritonitis outcome at month 1 and 3 including transfer to hemodialysis , death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as peritoneal dialysis-related peritonitis;
  • Age> 14 years
  • Maintenance peritoneal dialysis due to end-stage renal failure ≥3 months
  • Use of lactate glucose dialysate

排除标准

  • Those who cannot be followed up regularly
  • Reluctant to join this researcher

结局指标

主要结局

Prevalence of elevated eosinophils in peritoneal dialysis effluent

时间窗: Feb 18,2021 to December 31,2023

eosinophil number \>100 /mm3, or the proportion of polynuclear leukocytes \>10%.

次要结局

未报告次要终点

研究者

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

Dong Jie

Professor in Renal Divison,Department of Medicine

Peking University First Hospital

研究点 (1)

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