Severe falciparum malaria Infections and Infestations Malaria
Conditions
Interventions
Fluid resuscitation with either:
1. Human albumin solution
2. Gelofusine
3. Dextran 70
4. Hetastarch
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Kenyan children aged more than three months, either sex 2. Clinical features of severe falciparum malaria (impaired consciousness and or deep breathing) 3. Metabolic acidosis (base deficit more than or equal to eight)
Exclusion criteria
Exclusion criteria: 1. Children of families who decline consent 2. Children with: 2.1. Severe anaemia (haemoglobin less than 5 g/dl) 2.2. Cerebrospinal fluid (CSF) changes consistent with meningitis 2.3. Clinical features of pulmonary oedema (defined as clinical evidence presence of fine crepitations in both lungs plus oxygen saturations less than 95%) 2.4. Evidence of raised intracranial pressure (brain stem features of coning, systolic blood pressure more than 90% centile for age plus falling heart rate and/or papilloedema) 2.5. Any conditions that may contraindicate the use of volume replacement, e.g. established renal failure or known congenital heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The resolution of clinical features of shock and case fatality | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of major side effects or complications of volume resusciation: 1. Abnormal clotting indices 2. Pulmonary oedema 3. Raised intracranial pressure | — |
Countries
Kenya
Outcome results
None listed