A gold standard example of running a trial in Africa

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A trial called Fluid Expansion as Supportive Therapy (FEAST) has just been reported in the New England Journal of Medicine. This study involved over 3,000 children in six hospitals across Tanzania, Uganda & Kenya. It examined the effectiveness of a long-standing treatment used across the world called fluid resuscitation. This treatment involves giving seriously ill children large volumes or ‘boluses’ of intravenous fluids quickly through a drip in their first hour at hospital to try to reverse the deadly effects of shock. 

The children on the trial were divided randomly into three equally sized groups. Two groups were given emergency boluses of either albumin or saline in the first hour of arriving in hospital. After the first hour, the children were then given fluids slowly, to replace the amounts a sick child should drink. The third group was given fluids slowly from the first hour of admission but no additional bolus treatment.

The trial results showed that children given fluids more slowly did better, with a 48-hour survival rate of 92.7 per cent, compared with 89.4 per cent of those children given boluses. Compared with giving children fluids slowly, fluid resuscitation caused three additional children to die out of every hundred treated.

The trial was stopped early because the independent committee overseeing safety saw that giving boluses was unsafe. However, all children who took part in FEAST had a better chance of survival than is normally the case in Africa, in part due to extra training given to hospital staff to give emergency treatments, such as oxygen and providing medicines for malaria and other infections.  This was a very important finding because this is the first time anywhere in the world that fluid resuscitation has been evaluated for safety and effectiveness in such a large trial, even though it has been standard treatment for the last two decades in the United States, Europe and Australasia. Furthermore, the results go against the recommendations of the WHO and the normal practice in wealthy countries.

The clear findings from the FEAST trial do question the use of boluses for severe infections even in wealthy countries and more research is needed. However, the researchers have stressed the need to continue to use fluid resuscitation to treat diarrhoea and other conditions like burns and trauma, where children lose fluids. For these conditions, where fluid resuscitation will continue to be a vital life-saving treatment, they advise that current WHO recommendations should stay the same. Children with severe malnutrition were not included in the trial as fluids are not recommended as part of their treatment.

The study was coordinated by KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya in collaboration with scientists from Imperial and the Clinical Trials Unit of the Medical Research Council in London (MRC-CTU).

Attached to this article is a video clip describing the trial and the challenging environment. Throughout the film the trial team is congratulated for their management and conduct of such a complex study in these resource-limited settings.

Via this film we present this trial as a gold standard example of trial design, management and conduct, irrespective of location. The team should be well congratulated and be an example to others.

http://www.youtube.com/watch?v=hK9VUkL-DqU