Severe illness with shock due to sepsis or severe malaria Infections and Infestations Other septicaemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children (both males and females, age range >60 days and 2s 2.2. Lower limb temperature gradient 2.3. Weak radial pulse volume 2.4. Severe tachycardia Severe tachycardia: if 180 bpm; 12 months to 5 years: >160 bpm; >5 years: >140 bpm
Exclusion criteria
Exclusion criteria: One or more of the following at admission: 1. Severe acute malnutrition 2. Gastroenteritis 3. Conditions where intravascular volume expansion is contraindicated, namely chronic renal failure, pulmonary oedema 4. Non-infectious causes of severe illness: trauma, burns, intoxication 5. Children who have already received volume expansion using an isotonic volume expander during the current illness Severe malnutrition: visible severe wasting and/or kwashiorkor Gastroenteritis: >3 watery stools in previous 24 hours Pulmonary oedema: oxygen saturation <90% on pulse oximetry plus bilateral basal crepitations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-hospital mortality at 48 hours after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at 4 weeks after randomisation 2. Mortality or neurological sequelae at 4 weeks after randomisation 3. Neurological sequelae at 4 weeks after randomisation 4. Persistent neurological sequelae at 6 months after randomisation 5. Development of hypotensive shock within 48 hours of randomisation 6. Adverse event within 48 hours of randomisation (pulmonary oedema, intracranial hypertension, severe allergic reaction in those receiving albumin) | — |
Countries
Kenya, Tanzania, Uganda