Fluids in Shock (FiSh) External Pilot Study Version 1.0
Research type
Research Study
Full title
External pilot study to inform the design and conduct of the Fluids in Shock (FiSh) Trial
IRAS ID
195544
Contact name
David Inwald
Contact email
Sponsor organisation
Imperial College Heathcare NHS Trust
ISRCTN Number
ISRCTN15244462
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Children are now much more likely to survive a severe infection than ever before. This progress comes from a whole package of treatments including antibiotics, multiple rapid doses (boluses) of fluid (e.g. saline solution) into a child’s veins (‘fluid bolus therapy’) and support for breathing and heart function. We hope to improve the outcome of children with severe infection by refining one part of this package: by exploring what is the best amount of fluid to give in the earliest stages of treatment.\n\nWe are designing a clinical trial (called Fluids in Shock – FiSh) to find out whether giving less fluid per bolus to children with symptoms of a severe infection (septic shock) is better than giving a higher amount of fluid, as currently recommended.\n\nWe are conducting a pilot trial, a smaller version of the trial we would like to run. We will recruit 108 children admitted with septic shock to emergency departments in 14 NHS hospitals over nine months. Patients will be randomly allocated to receive either fluid boluses of 10 ml/kg (intervention) or 20 ml/kg (usual care) every 15 minutes for up to four hours.\n\nWe would also like to ask parents/legal representatives who do and do not give consent to the study their views on the consenting process. Questionnaires (100-150) and telephone interviews (15-25) will be used to explore the parents/legal representatives’ acceptability of the study, including the approach to recruitment, consenting procedures and participant information materials. We will also hold three focus groups with the hospital research teams to explore their experiences of screening, recruiting, randomising and consenting parents/legal representatives to the pilot trial.\n\nBy doing this study, we hope to find out whether the trial is possible and, if so, how it should be done.
REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/0854
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion