Fluid Expansion As Supportive Therapy in critically ill African children.
Early rapid fluid resuscitation increases risk of death in critically ill children with shock and febrile illnesses at hospitals in Africa.
What was this study about?
In hospitals throughout sub-Saharan Africa, mortality from malaria and other severe infections in childhood remains at 15-30%. Over 50% of these deaths occur within 24 hours of admission to hospital. Currently, antimalarial and antimicrobial drugs are the mainstay of treatment. In high-income countries children with shock caused by severe infections are also given large volumes of fluids (fluid resuscitation), with the aim of restoring normal blood circulation. In sub-Saharan Africa this approach is not normally used. Before this trial took place little was known about using fluid resuscitation for children in sub-Saharan Africa for treating shock.
The FEAST trial was a multi-centre < randomised controlled trial that evaluated different fluid resuscitation strategies in children presenting to hospital with severe infections and clinical evidence of impaired perfusion (where the blood is not circulating to all parts of the body in the normal manner). Children with fluid losses due to gastroenteritis, burns or blood loss were not included in this trial.
What difference did this study make?
The results showed that the children who were given small amounts of fluids slowly did better than those that were given rapid fluid resuscitation. Compared to maintenance fluids, fluid resuscitation caused 3 more children to die out of every hundred treated. This was the same for both types of resuscitation fluid that were tested: Human Albumin 5% or normal saline 0.9%.
These results mean that children in sub-Saharan Africa with the conditions studied should not be given fluid resuscitation. But fluid resuscitation remains a vital life saving treatment anywhere in the world to treat diarrhoea and other conditions such as burns and trauma where children are losing fluid. The video below explains what the trial was about and what the results mean.
As the practice of fluid resuscitation has been standard in the US, Europe and Australasia for over 2 decades, and is WHO recommended, this was a highly unexpected result. Further research is now needed to evaluate the safety and effectiveness of fluid resuscitation where it is already a standard practice. The results from an African context may not be directly applicable to wealthy countries where fluid resuscitation is part of a 'package of care' which includes access to sophisticated life support equipment such as ventilation.
This trial has given valuable information about fluid resuscitation in an African setting and encourages more research in this topic in areas where fluid resuscitation is standard practise. The trial team are now working to communicate the results of the study widely, to encourage inclusion of the recommendations in treatment guidelines. They have received an Alexander Fleming Dissemination Award to fund this communication work.
The trial was run to a high standard and paves the way for more clinical trials in paediatric emergency medicine in Africa.
Type of study
Who funded the study?
The Medical Research Council.
When did it take place?
The trial started in January 2009, and was closed early before planned recruitment was finished, in January 2011 following advice from the data and safety monitoring committee, because of harm to children in the rapid fluid resuscitation arms compared with giving maintenance fluids only. A paper with the main results of the trial was published in the New England Journal of Medicine in June 2011.
Where did it take place?
Kenya: Kilifi District Hospital
Uganda: Mulago Hospital (Kampala), Soroti Regional Hospital, St Mary's Hospital (Lacor), Mbale Regional Referral Hospital
Tanzania: Teule Hospital
Who was included?
3170 children over 60 days old and less than 12 years took part in the FEAST trial; the average age was 2 years. They all had impaired consciousness or respiratory distress (increased work of breathing) plus clinical evidence of impaired perfusion (blood not flowing well to areas like the skin). They had a wide range of diagnoses, but malaria was the most common (in two thirds) and septicaemia was also common. Children with diarrhoea, burns, traumatic injuries or who were malnourished were excluded from the trial.
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Why did fluid resuscitation increase mortality in African children with shock in the FEAST trial?
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The FEAST team's reflections on winning BMJ Research Paper of the Year award
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Increased deaths of children in shock, related to fluid resuscitation, are caused by cardiovascular collapse
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New film: FEAST - An anatomy of a clinical trial
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