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临床试验/ISRCTN69856593
ISRCTN69856593已完成未知

A randomised trial of fluid resuscitation strategies in African children with severe febrile illness and clinical evidence of impaired perfusion

Imperial College of Science, Technology and Medicine (UK)0 个研究点目标入组 3,141 人开始时间: 2009年1月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
3,141

研究概览

简要总结

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Children (both males and females, age range >60 days and <12 years) with severe illness and clinical evidence of impaired perfusion in whom there is uncertainty as to the benefits of immediate fluid resuscitation and what type of fluid to give.
  • Severe illness and impaired perfusion defined as follows:
  • 1. Severe illness: one or more of the following:
  • 1.1. Impaired consciousness: prostration or coma
  • 1.2. Respiratory distress
  • Prostration: inability to sit unsupported, or to breast feed if < 9months
  • Coma: inability to localise a painful stimulus
  • Respiratory distress: Deep breathing or increased work of breathing
  • 2. Impaired perfusion: one or more of the following:
  • 2.1. Capillary refill time >2s
  • 2.2. Lower limb temperature gradient
  • 2.3. Weak radial pulse volume
  • 2.4. Severe tachycardia
  • Severe tachycardia: if <12 months: >180 bpm; 12 months to 5 years: >160 bpm; >5 years: >140 bpm

排除标准

  • One or more of the following at admission:
  • 1. Severe acute malnutrition
  • 2. Gastroenteritis
  • 3. Conditions where intravascular volume expansion is contraindicated, namely chronic renal failure, pulmonary oedema
  • 4. Non-infectious causes of severe illness: trauma, burns, intoxication
  • 5. Children who have already received volume expansion using an isotonic volume expander during the current illness
  • Severe malnutrition: visible severe wasting and/or kwashiorkor
  • Gastroenteritis: >3 watery stools in previous 24 hours
  • Pulmonary oedema: oxygen saturation <90% on pulse oximetry plus bilateral basal crepitations

研究者

发起方
Imperial College of Science, Technology and Medicine (UK)

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