跳至主要内容
临床试验/NCT03433508
NCT03433508撤回不适用

Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家开始时间: 2018年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Mortality in both groups

研究概览

简要总结

Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cirrhosis with septic shock.
  • Age >18 years

排除标准

  • Previous severe adverse reaction with blood products,
  • Disseminated intravascular coagulopathy
  • Active gastrointestinal bleeding
  • Intracranial bleeding
  • Chronic Kidney disease with Maintenance Hemodialysis
  • Pulmonary Edema
  • Congestive Heart Failure
  • Lack of informed consent

结局指标

主要结局

Mortality in both groups

时间窗: 28 dyas

次要结局

  • Length of ICU (Intensive Care Unit) stay(28 days)
  • Requirement of mechanical ventilation in both groups(28 days)
  • Improvement in vasopressors in both groups(28 days)
  • Incidence of complications in both groups(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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