Background: There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric
sepsis in the developed world despite evidence that excess fluid may be associated with harm.
Objectives: To determine the feasibility of the Fluids in Shock (FiSh) trial – a RCT comparing restricted fluid
bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK.
Design: (1) Qualitative feasibility study exploring parents’ views about the pilot RCT. (2) Pilot RCT over a
9-month period, including integrated parental and staff perspectives study.
Setting: (1) Recruitment took place across four NHS hospitals in England and on social media. (2) Recruitment
took place across 13 NHS hospitals in England.
Participants: (1) Parents of children admitted to a UK hospital with presumed septic shock in the previous
3 years. (2) Children presenting to an emergency department with clinical suspicion of infection and shock
after 20 ml/kg of fluid. Exclusion criteria were receipt of > 20 ml/kg of fluid, conditions requiring fluid
restriction and the patient not for full active treatment (i.e. palliative care plan in place). Site staff and
parents of children in the pilot were recruited to the perspectives study.
Interventions: (1) None. (2) Children were randomly allocated (1 : 1) to 10- or 20-ml/kg fluid boluses
every 15 minutes for 4 hours if in shock.
Main outcome measures: (1) Acceptability of FiSh trial, proposed consent model and potential outcome
measures. (2) Outcomes were based on progression criteria, including recruitment and retention rates,
protocol adherence and separation between the groups, and collection and distribution of potential
outcome measures.
Results: (1) Twenty-one parents were interviewed. All would have consented for the pilot study.
(2) Seventy-five children were randomised, 40 to the 10-ml/kg fluid bolus group and 35 to the 20-ml/kg
fluid bolus group. Two children were withdrawn. Although the anticipated recruitment rate was achieved,
there was variability across the sites. Fifty-nine per cent of children in the 10-ml/kg fluid bolus group and
74% in the 20-ml/kg fluid bolus group required only a single trial bolus before shock resolved. The volume
of fluid (in ml/kg) was 35% lower in the first hour and 44% lower over the 4-hour period in the 10-ml/kg
fluid bolus group. Fluid boluses were delivered per protocol (volume and timing) for 79% of participants
in the 10-ml/kg fluid bolus group and for 55% in the 20-ml/kg fluid bolus group, mainly as a result of
delivery not being completed within 15 minutes. There were no deaths. Length of hospital stay, paediatric
intensive care unit (PICU) transfers, and days alive and PICU free did not differ significantly between the
groups. Two adverse events were reported in each group. A questionnaire was completed by 45 parents,
20 families and seven staff were interviewed and 20 staff participated in focus groups. Although a
minority of site staff lacked equipoise in favour of more restricted boluses, all supported the trial.
Conclusions: Even though a successful feasibility and pilot RCT were conducted, participants were not as
unwell as expected. A larger trial is not feasible in its current design in the UK.
Future work: Further observational work is required to determine the epidemiology of severe childhood
infection in the UK in the postvaccine era.
Trial registration: Current Controlled Trials ISRCTN15244462.