A huge number of studies are published in journals everyday. Most are read with interest by people involved in the area in which they are published but few every reach the attention of the world’s media. The FEAST study is an exception to this; it attracted a huge amount of attention, the headline from the BBC news story – “Africa trial questions shock treatment for children” was typical of coverage of this trial.
The use of fluid boluses for shock is an international standard, the American College of Critical Care Medicine recommend the use of 60mls per kg of fluid for a child with a fever who has shock. However, in resource-poor countries these boluses are simply not available.
FEAST – Fluid Expansion as Supportive Therapy – was published in June 2011 in the New England Journal of Medicine with the aim of evaluating the effect of fluid boluses and early fluid resuscitation for shock in febrile children in Sub-Saharan Africa. This was a randomised controlled trial carried out in 6 hospitals inKenya,Tanzania and Uganda. The trial assessed the effects of giving a fluid bolus to children with a febrile illness and impaired perfusion (i.e. children with hypovolaemic shock). Children were randomised into two groups:
- Stratum A – children without severe hypotension – randomised to receive either a saline bolus (20mls per kg), an albumin bolus (20mls per kg) or no bolus (control group)
- Stratum B – children with severe hypotension – randomised to receive saline bolus (40mls per kg) or albumin bolus (40mls per kg)
The protocol was changed in June 2010 and initial boluses were increased to 40ml per kg in stratum A and 60mls per kg in stratum B. Children from the age of 60 days to 12 years were included and the exclusion criteria were children with severe malnutrition, diarrhoea, burns, surgery and trauma. All children received appropriate treatment for their condition as well as being involved in the trial.
The primary endpoint was mortality at 48 hours after randomisation.
The study was stopped in January 2011 after the independent data and safety monitoring committee reviewed the 5th interim analysis from the study and recommended stopping owing to safety concerns in both fluid bolus groups.
The headline finding – 48 hour mortality:
- 10.6% in the albumin bolus group
- 10.5% in the saline bolus group
- 7.3% in the control group
The relative risk for any bolus vs control was remarkable – 1.44 (P=0.003). The results were found to be consistent across the trial sites and across the subgroups even in respect to the underlying conditions (malaria, coma, sepsis, acidosis and severe anaemia).
The authors of the paper concluded:
The results of this study challenge the importance of fluid resuscitation as a lifesaving intervention in resource limited setting for children with shock who do not have hypotension and raise questions regarding fluid-resuscitation guidelines in other settings as well
This week I emailed Professor Kathryn Maitland for her thoughts ahead of our discussion and I thank her for taking the time to email me back. Her response:
The major take home message is that we were all surprised by the result. There was no ‘signal’ from the SAE’s and the clinicians involved in the trial — said they all saw children ‘improve’ on boluses and believed that boluses were good. This is why trials are important.
Overall, mortality was lower than they had previously experienced– which was probably due to training of all staff involved in paediatric care.
Professor Maitland also highlights the FEAST study trial video which in her words “takes you to the bedside and puts the trial into context”.
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Tomorrow I will be posting the discussion points for Sunday evening’s journal club meeting and I look forward to critiquing this fascinating paper.
Thank you to @welsh_gas_doctor for his help with this summary.