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临床试验/ISRCTN34508212
ISRCTN34508212已完成未知

A pilot study of mild induced hypothermia for severe falciparum malaria

niversity of Oxford (UK)0 个研究点目标入组 10 人开始时间: 2013年10月23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
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age 16-60 years
  • 2. Informed consent obtained (plus parental/guardian assent if 16 or 17 years old)
  • 3. Time of commencement of artesunate =18 hrs before therapy
  • 4. Any level of Plasmodium falciparum parasitemia, and one or more of the following criteria:
  • 4.1. Acute renal failure (creatinine >265umol/L)
  • 4.2. Hyperbilirubinemia (total bilirubin >50 umol/L) with either renal impairment (creatinine >130umol/L) or parasitemia of >100,000 parasites/uL
  • 4.3. Blackwater fever
  • 4.4. Hyperparasitemia (>10% parasitised red cells)
  • 4.5. Cerebral malaria (Glasgow coma score <11)
  • 4.6. Hypoglycemia
  • 4.7. Respiratory distress (RR >32)
  • 4.8. Venous bicarbonate 12-15 meq/L (pilot phase) or 8-15 meq/L

排除标准

  • 1. Pregnancy or lactation
  • 2. Diabetes
  • 3. Serious pre-existing disease (cardiac, hepatic, kidney)
  • 4. History of contraindications to hypothermia (Raynaud?s disease, Cryoglobulinemia, Sickle Cell disease, serum cold agglutinins, Buerger?s disease)
  • 5. Bleeding disorders (e.g., hemophilia)
  • 6. An intranasal obstruction or known skull base fracture

研究者

发起方
niversity of Oxford (UK)

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