Anatomy of a clinical trial – FEAST

Should you give IV fluid boluses to acutely sick African children, in shock with Malaria, Sepsis, Meningitis and other febrile illnesses? Will this help to help keep them alive until antibiotics, antimalarials or other treatments kick in? Twenty years of medical practice said you should, and that fluid resuscitation can cheat death and buy time. But this large randomized controlled clinical trial (3000+ children across seven sites) – the only one ever done to evaluate fluid resuscitation in children – found fluid boluses to be harmful, resulting in higher mortality. It was true of all febrile illnesses tested in the trial and for all definitions of shock. But despite only low-quality evidence to support fluid resuscitation, the FEAST results remain hugely controversial seven years on.

These two films use the FEAST trial to lay open the workings of a randomised controlled clinical trial. In FEAST, the staff running the trial were able to see which children received fluid boluses and which did not. They consistently noticed that symptoms of shock improved in children who received boluses. Arms and legs warmed up. Sometimes children even came out of a coma. It was similar experience recorded in previous observational studies that had led to the adoption of fluid resuscitation for children in shock and led to it becoming worldwide standard practice for over twenty years. So when asked on camera to predict the result of the trial, the FEAST staff almost all believed that fluid boluses would be beneficial. In fact, the trial showed the opposite – that the improvement in symptoms did not translate to fewer deaths. On the contrary, the trial was stopped early with a statistically significant result showing harm. The disbelief shown in the film on the faces of the nurses and doctors who ran the study at being told the result was echoed in the wider medical community, resulting in a long and sometimes heated debate about the future of fluids in children’s emergency medicine.