Status: Closed to recruitment
What is this study about?
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 (feasibility study) involves interviews with parents/guardians whose child has been recently admitted to a hospital with severe infection. The views of these parents/guardians are important to help us find the best way to do the trial, including how we should explain the study to parents/guardians and how we should seek informed consent when a child is very ill.
Phase two (pilot study) will be conducted in 12 NHS hospitals around the UK and will include 108 children. 54 children will be randomly allocated to receive less fluid (at 10 ml per kg) and the other 54 children to receive a usual fluid amount (at 20 ml per kg). We will test the various trial processes and procedures, which are informed by the interviews from phase one.
When is it taking place?
Phase one started in December 2015 and finished in May 2016.
Phase two started in July 2016 and finished recruitment in March 2017.
Who is leading the study?
Dr David Inwald, Imperial College Healthcare NHS Trust, London
This study is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: 13/04/105)