Mild induced hypothermia for severe falciparum malaria

Not Applicable

Completed

• Conditions: Malaria; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN34508212
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-23
• Study Completion: 2015-05-01
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. In-hospital mortality<br> 2. 30 day mortality<br> 3. Neurological outcome at day 30<br> 4. Safety<br> Primary endpoints will be mortality and neurological state at baseline and discharge from hospital<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Parasite clearance time<br> 2. Clinical and biochemical measures (see below).<br> 3. Biochemical and hemodynamic measures at the start and completion of therapy will also be compared<br> 4. Area under the curve for microvascular reactivity by reactive hyperemia-peripheral artery tonometry (RH-PAT) [0-25 hrs]<br> 5. Endothelial function [near-infrared reflectance spectroscopy (NIRS) and RH-PAT]<br> 6. Lactate clearance<br> 7. Improvement in microvascular obstruction [Orthogonal Polarization Spectral (OPS) imaging]<br> 8. Change in tissue oxygen consumption (measured by NIRS occlusion phase)<br> 9. Change in NO production<br> 10. Change in red cell deformability<br> 11. Changes in CSF markers of neuronal and axonal damage and astroglial activation<br>