Extrait

Background and study aims Septic shock is a life-threatening condition in which the blood pressure drops to dangerously low levels because of a serious blood infection (sepsis). Children are now much more likely to survive a septic shock than ever before. This progress comes from a whole package of treatments including antibiotics, multiple rapid doses (boluses) of fluid (saline (salt water) solution) into a child’s veins (‘fluid bolus therapy’) and support for breathing and heart function. This study is looking at refining the fluid bolus therapy part of this package by exploring what the best amount of fluid to give in the earliest stages of treatment is. In order to explore this, the study will monitor children to find out if giving less fluid per bolus to children with symptoms of a septic shock is better than giving a higher amount of fluid, as currently recommended. The aim of this study is to conduct a small version of the study to find out how feasible the study methods are and to find out if it is possible to recruit enough children to take part. Who can participate? Children under 16 years of age who are showing signs of septic shock, their parents or legal guardians, and hospital research teams. What does the study involve? In the first part of this study, children are randomly allocated to one of two groups. Those in the first group receive the current recommended bolus (dose) fluid therapy, of 20 ml/kg (maximum 1000 ml per bolus) every 15 minutes for four hours, until the signs of shock have gone or there are signs of fluid overload (a condition where there is too much fluid in the blood). Those in the second group receive smaller boluses of 10 ml/kg (maximum 500 ml per bolus) according to the same schedule. The type of fluids and other treatments given are left up to the medical team to decide. For both groups, the amount of fluid given to the children is recorded. In the second part of the study, parents/legal guardians of children participating in the first part of the study complete a number of questionnaires and telephone interviews to find out their views on the study process. Three focus groups with the hospital research teams are also held to explore their experiences of the study processes and consenting parents/legal representatives to the first part of the study. What are the possible benefits and risks of participating? It is not known whether there will be any additional benefits involved with participating in this study, however this study will help to improve the future treatment of children with septic shock. There are no notable risks involved with taking part. Where is the study run from? Thirteen NHS children’s hospitals in England (UK) When is the study starting and how long is it expected to run for? December 2015 to April 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Dr David Inwald (scientific) 2. Ms Ruth Canter (public) ([email protected])

Critère d'inclusion

• Sepsis, Septic shock

Liens

• ictrp
• isrctn