NCT00760032撤回4 期
Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients
Florencia Vargas-Vorackova1 个研究点 分布在 1 个国家开始时间: 2008年9月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Lipopolysaccharide binding protein plasma levels
研究概览
简要总结
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Cirrhosis
- •No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
- •No antibiotic use in previous 6 weeks
- •Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
- •Absence of GI bleeding or encephalopathy
- •Signature of informed consent
排除标准
- •Ciprofloxacin contraindication
- •Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
- •> 13 Child-Pugh points
- •Inability to attend to regular visits
- •Current alcohol intake
- •Terminal disease with < 24 week expected survival
研究组 & 干预措施
Active
Experimental
Ciprofloxacin
干预措施: Ciprofloxacin (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Lipopolysaccharide binding protein plasma levels
时间窗: 24 weeks
次要结局
- Severe infection(24 weeks)
- Pro- and anti-inflammatory cytokine secretion by PBMN cells(24 weeks)
研究者
Florencia Vargas-Vorackova
Doctor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
研究点 (1)
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