Mild induced hypothermia for severe falciparum malaria
| ISRCTN | ISRCTN34508212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34508212 |
| Secondary identifying numbers | V1.3 |
- Submission date
- 19/06/2013
- Registration date
- 23/10/2013
- Last edited
- 06/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Mild hypothermia (when body temperature drops below 35°C) has been shown to be protective in many situations in intensive care and this study aims to find out whether it could help patients with severe and cerebral malaria. This is a pilot (small scale) study.
Who can participate?
Patients admitted to intensive care with severe malaria
What does the study involve?
All patients are cooled to between 32 and 34°C using a cooled salt solution injected through their veins, in addition to standard treatment.
What are the possible benefits and risks of participating?
This technique may reduce death or brain damage from severe malaria
Where is the study run from?
This study is run from University College Hospital, London, UK and Chittagong Medical College, Chittagong, Bangladesh
When is the study starting and how long is it expected to run for?
May 2014 to May 2015
Who is funding the study?
Oxford University (UK)
Who is the main contact?
Dr Brian Angus
brian.angus@ndm.ox.ac.uk
Contact information
Scientific
Rm7400, L7 The John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| brian.angus@ndm.ox.ac.uk |
Study information
| Study design | Non-randomised pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pilot study of mild induced hypothermia for severe falciparum malaria |
| Study objectives | Mild induced hypothermia is safe and efficacious in severe falciparum malaria. |
| Ethics approval(s) | The Oxford Tropical Research Ethics Committee (OxTREC) 06-12 |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | 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 until discharge from the hospital. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/05/2014 |
| Completion date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy or lactation 2. Diabetes 3. Serious pre-existing disease (cardiac, hepatic, kidney) 4. History of contraindications to hypothermia (Raynauds disease, Cryoglobulinemia, Sickle Cell disease, serum cold agglutinins, Buergers disease) 5. Bleeding disorders (e.g., hemophilia) 6. An intranasal obstruction or known skull base fracture |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- Bangladesh
- England
- United Kingdom
Study participating centre
OX3 9DU
United Kingdom
Sponsor information
University/education
Centre for Tropical Medicine
Churchill Hospital
Headington
Oxford
OX9 9LJ
England
United Kingdom
| paul.hogben@ndm.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/08/2020: No publications found.
09/08/2017: No publications found, verifying study status with principal investigator.
