Fluids in Shock (FiSh) Feasibility Study Version 1.0
Research type
Research Study
Full title
Feasibility study to inform the design and conduct of the Fluids in Shock (FiSh) Trial
IRAS ID
191348
Contact name
David Inwald
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Children are now much more likely to survive any serious infection than ever before. This progress comes from a whole package of treatments including antibiotics, infusions 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 survival further by refining one part of this package of treatment: by exploring what is the best amount of fluid to give critically ill children in the earliest stages of care.\nWe are designing a clinical trial (called Fluids in Shock – FiSh) to find out whether giving less fluid bolus therapy to children with symptoms of a severe infection (septic shock) is better than giving a higher amount of fluid, as currently recommended.\n\nWe would like to interview 15-25 parents/legal representatives whose children have been admitted to hospital and treated for severe infection in the last three years. Parents/Legal representatives will be identified via UK emergency departments, paediatric intensive care units and online support groups/social media.\nDuring interviews, we will review and explore: acceptability of the FiSh Trial; potential barriers to recruitment and potential solutions; patient and parent information (including patient information sheets, leaflets and posters); decision-making and research without prior consent (deferred consent); and potential patient-centred outcome measures (e.g. what outcomes would be important to parents/legal representatives of children with severe infection?).\n\nBy speaking to parents/legal representatives, we hope to find out whether the trial is possible and, if so, how it should be done.\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0913
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion