ISRCTN34508212Completed未知
A pilot study of mild induced hypothermia for severe falciparum malaria
niversity of Oxford (UK)0 sites10 target enrollmentStarted: October 23, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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