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Fluid Expansion As Supportive Therapy in critically ill African children

A randomised trial of fluid resuscitation strategies in African children with severe febrile illness and clinical evidence of impaired perfusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69856593
Enrollment
2880
Registered
2009-01-21
Start date
2008-12-15
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe illness with shock due to sepsis or severe malaria Infections and Infestations Other septicaemia

Interventions

This is a three-arm randomised open controlled trial comparing two active fluid resuscitation strategies to control (no bolus). 2,880 children will be assigned in a ratio of 1:1:1 to one of the three
144 with decompennsated shock will be randomised to human albumin solution (HAS) or saline. Three resuscitation strategies: 1. Immediate volume resuscitation with norm

Sponsors

Imperial College of Science, Technology and Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
In-hospital mortality at 48 hours after randomisation.

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026