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This is a landmark paper in medicine, and is a remarkable achievement both in its scale and its contribution to medical knowledge. It is a pragmatic, randomised, controlled trial, conducted in 6 hospitals in Kenya, Tanzania and Uganda. Basically it assesses the effect of a bolus of albumin vs saline vs no bolus (all got maintenance only), in children with febrile medical illness and impaired perfusion. A second stratum of children with severe hypotension or decompensated shock had albumin or saline boluses only. WHO guidelines recommend reserving the practice of fluid resuscitation for children with advanced shock. As most sub-Saharan hospitals do not have intensive care or ventilation capabilities, and limited triage and resuscitation capabilities, fluid bolus is not widely practiced. The primary outcome was 48-hour mortality. There is a youtube presentation of the study, and a link to the trial site; http://www.feast-trial.org/ http://www.youtube.com/watch?v=hK9VUkL-DqU What they did - Taught the centers involved how to recognise, resuscitate, and treat febrile children - Randomised 60 day to 12 yr old children with severe febrile illness to albumin bolus vs N.Saline bolus vs maintenance - Treated hypotension in all groups with fluid bolus - Randomised 3141 patients then trial stopped after 5th interim analysis owing to safety concerns in both bolus groups. What they found - Completely unexpected outcome of 3.3% absolute risk of death at 48-hours (7.3% control, 10.5 and 20.6% fluid bolus), and 4% increase in risk of death, neurological sequelae or both by 4-weeks. This increase was present across all subgroups. - No difference in mortality in the strata of patients with severe hypotension or decompensated shock 69% albumin vs 56% saline). This included children with moderate hypotension. What it doesn't say - Children with gastroenteritis and diarrhoea shouldn't be volume replaced to normovolaemia - Hypotensive or shocked children shouldn't get fluid Implications for 1st world - Should children get boluses  not clear, as access to sophisticated ICU's with ventilation and inotropes - Need repeat study in 1st world Summary The enormity of their problem and their achievement cannot be overstated. This is a condition that kills 2 millions children each year in sub-Saharan Africa annually. The mortality in children with a severe febrile illness of 7.3-10% and with shock of >50% is sobering. To conduct a large landmark trial to a very high standard (excellent protocol adherence and internal validity) in a 3rd world environment is incredible.