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Emergency fluid bolus therapy studies: first do no harm
  1. Kathryn Maitland1,2
  1. 1Department of Paediatrics, Faculty of Medicine, Imperial College London, London, UK
  2. 2Clinical Trial Facility, KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
  1. Correspondence to Professor Kathryn Maitland, Department of Paediatrics, Faculty of Medicine, Imperial College London, London SW7 2AZ, UK; k.maitland{at}imperial.ac.uk

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Nobody could have been more surprised than the Fluid Expansion As Supportive Therapy (FEAST) trial clinicians when they heard the results of our 2011 phase III randomised controlled study in six East African clinical centres in Kenya, Tanzania and Uganda.1 Based on what they had witnessed at the bedside in children with severe febrile illness and impaired perfusion, they had all expected fluid bolus therapy (FBT) as compared with no bolus (but solely maintenance fluids at 4 mL/kg/hour) to have a better outcome. Even though FBT leads to substantially better early shock reversal, subsequently it results in excess 48-hour and 28-day mortality. The chief mode of excess mortality was cardiovascular collapse and not fluid overload (figure 1).2 Notable is that the vast majority of children only received a 20 mL/kg bolus of either 5% albumin or 0.9% saline, yet this intervention caused excess mortality in all subgroups (including a large subgroup with sepsis), across all ages, for all definitions of shock, and at each centre. This surprising finding is precisely why we need to do clinical trials!

Figure 1

Cumulative incidence of mortality for bolus combined and no bolus arms by terminal clinical events for 297 children who died within 48 hours (from figure 7 from ref2).

To date, the FEAST trial is the only completed phase III …

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