FEAST
Fluid Expansion As Supportive Therapy
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 3170 African children with severe febrile illness and impaired perfusion, fluid boluses increased 48-hour mortality compared with no bolus.
N
3.170
Design
Multicentre randomised controlled trial in children aged 60 days to 12 years with severe febrile illness and impaired perfusion at hospitals in Uganda, Kenya and Tanzania; stratum A randomised 1:1:1 to a 20–40 ml/kg bolus of 5% albumin, an equivalent bolus of 0.9% saline, or no bolus, stratum B (severe hypotension) to albumin or saline bolus only; malnutrition and gastroenteritis excluded; recruitment halted early on the recommendation of the data and safety monitoring committee after 3141 of a projected 3600 stratum A children.
Endpunkt
48-hour mortality; secondary endpoints included pulmonary oedema, raised intracranial pressure, and death or neurological sequelae at 4 weeks.
Ergebnis48-hour mortality 10.6% with albumin bolus, 10.5% with saline bolus and 7.3% with no bolus (any bolus vs control RR 1.45, 95% CI 1.13–1.86, P=0.003; saline vs control RR 1.44, 95% CI 1.09–1.90, P=0.01; albumin vs saline RR 1.01, 95% CI 0.78–1.29, P=0.96). 4-week mortality 12.2%, 12.0% and 8.7% (P=0.004 bolus vs control). Neurological sequelae 2.2%, 1.9%, 2.0% (P=0.92); pulmonary oedema or raised intracranial pressure 2.6%, 2.2%, 1.7% (P=0.17). In stratum B, 9 of 13 albumin and 9 of 16 saline patients died (P=0.45). Harm was consistent across centres and across malaria, coma, sepsis, acidosis and severe anaemia subgroups.
Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011;364(26):2483-2495. 10.1056/nejmoa1101549