Severe malaria Infections and Infestations Malaria
Conditions
Interventions
Open phase II randomised trial comparing the safety and efficacy of volume expansion with 0.9% saline or human albumin to control in children with severe malaria and moderate acidosis (base deficit of
Sponsors
Imperial College London (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. A clinical feature of severe malaria (prostration, coma or deep breathing) plus P. falciparum 2. A base deficit of more than eight 3. Parental consent
Exclusion criteria
Exclusion criteria: 1. Clinical features of oedematous malnutrition 2. Features suggestive of pulmonary oedema (oxygen saturations <90% and bilateral creptitations) 3. Raised intracranial pressure (unequal pupillary reaction to light and/or raised blood pressure concurrent with bradycardia) 3. Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in acidosis by eight hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death 2. Severe adverse events 3. Neurological sequalae | — |
Countries
Kenya
Outcome results
None listed