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临床试验/NCT02085915
NCT02085915已完成不适用

Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Centre Hospitalier Departemental Vendee22 个研究点 分布在 2 个国家目标入组 649 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
649
试验地点
22
主要终点
Sensitivity and Specificity

研究概览

简要总结

The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female over 18 years
  • •Presence of ascites due to cirrhosis
  • •Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).
  • •Hospitalization to perform a paracentesis evacuated outpatient
  • •Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.

排除标准

  • •Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
  • •chylous ascites,
  • •Hemorrhagic Ascites
  • •Biliary Ascites (straw)
  • •Ascites heterogeneous appearance
  • •Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
  • •Patient receiving imipenem IV.
  • •Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.

研究组 & 干预措施

strip Peri Screen

Other

干预措施: strip Peri Screen (Other)

结局指标

主要结局

Sensitivity and Specificity

时间窗: Baseline

Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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