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临床试验/NCT02114710
NCT02114710已完成3 期

Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Nanjing PLA General Hospital0 个研究点目标入组 240 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
240
主要终点
death

研究概览

简要总结

The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

详细描述

Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients(age≧18y)
  • Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)

排除标准

  • Lactation
  • Mental disorders
  • Disseminated cancer
  • Secondary cancers
  • Inflammatory bowel disease, or diseases hindering epidural analgesia

研究组 & 干预措施

Hydrocortisone

Experimental

little doses of hydrocortisone

干预措施: Hydrocortisone (Drug)

结局指标

主要结局

death

时间窗: 30 days after inclusion

次要结局

  • clinical perioperative complications(30 days after inclusion)
  • clinical complications(30 days after inclusion)

研究者

发起方
Nanjing PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Tao

Nanjing PLA General Hospital

Nanjing PLA General Hospital

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