Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
All patients will receive mild induced hypothermia along with the standard treatment. Patients will be cooled using cold intravenous saline and external cooling blankets. Patients will be followed up
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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 32) 4.8. Venous bicarbonate 12-15 meq/L (pilot phase) or 8-15 meq/L
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. In-hospital mortality 2. 30 day mortality 3. Neurological outcome at day 30 4. Safety Primary endpoints will be mortality and neurological state at baseline and discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parasite clearance time 2. Clinical and biochemical measures (see below). 3. Biochemical and hemodynamic measures at the start and completion of therapy will also be compared 4. Area under the curve for microvascular reactivity by reactive hyperemia-peripheral artery tonometry (RH-PAT) [0-25 hrs] 5. Endothelial function [near-infrared reflectance spectroscopy (NIRS) and RH-PAT] 6. Lactate clearance 7. Improvement in microvascular obstruction [Orthogonal Polarization Spectral (OPS) imaging] 8. Change in tissue oxygen consumption (measured by NIRS occlusion phase) 9. Change in NO production 10. Change in red cell deformability 11. Changes in CSF markers of neuronal and axonal damage and astroglial activation | — |
Countries
Bangladesh, United Kingdom
Outcome results
None listed