A combined feasibility and external pilot study to inform the design and conduct of the Fluids in Shock
FiSh: Fluids in Shock
Dr David Inwald
Dr Kerry Woolfall, Dr Mark Lyttle, Dr Nicola Jones, Honorary Professor Simon Nadel, Mr Paul Mouncey, Mrs Anjali Carter, Professor David Harrison, Professor Kathryn Rowan, Professor Mark Peters, Professor Michael Levin
Imperial College Healthcare NHS Trust
NIHR Evaluation Trials and Studies Coordinating Centre (NETS)
Currently in the UK, children with a severe infection (septic shock) tend to be treated with liberal amounts of fluid. However, very few research studies support this approach. A recent research study conducted in Africa found that restricting the amount of fluid given to children with a severe infection resulted in fewer deaths. However, the results of this study may not directly apply to children in the UK due to differences in healthcare services, child nutrition and causes of infection. Still, it has emphasised the need for more research in this area.
The Fluids in Shock (FiSh) trial aims to investigate whether giving less fluid is more beneficial to children with a severe infection than the amounts of fluid currently recommended in the UK. As large clinical trials are expensive to conduct, it is important to demonstrate that a trial can be done and that the different components of a trial can all work together. Therefore, before embarking on the full FiSh trial, we are conducting an 18-month combined feasibility and pilot study in two phases.
Phase one started in December 2015 and finished in May 2016.
Phase two started in July 2016 and finished recruitment in March 2017.