A pilot study of mild induced hypothermia for severe falciparum malaria

niversity of Oxford (UK)0 sites10 target enrollmentStarted: October 23, 2013Last updated: August 17, 2020

Conditions

Trial Snapshot

No summary available.

•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

•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

Sponsor

niversity of Oxford (UK)