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临床试验/EUCTR2013-003556-20-DK
EUCTR2013-003556-20-DK进行中(未招募)1 期

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial - INSTINCT

Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 100 人开始时间: 2014年2月12日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Necrotizing soft tissue infection based on surgical findings
  • Age >=18 years
  • Admitted to or planned to be admitted to the ICU at Copenhagen University Hospital, Rigshospitalet
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 75

排除标准

  • >48 hour from the primary diagnosis to arrival at Copenhagen University Hospital, Rigshospitalet
  • More than one dose of intavenous, polyspecific immunoglobulin G (IVIG) given within current admission
  • Known hypersensitivity to IVIG
  • Hyperprolinaemia
  • Pregnancy or breast feeding

研究者

发起方
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet

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