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
- 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21615299 2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23496872 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31196803 (added 17/06/2019)
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
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