OBJECTIVE: To determine the feasibility of Fluids in Shock, a randomised controlled trial (RCT) of restricted fluid bolus volume (10 mL/kg) versus recommended practice (20 mL/kg).

DESIGN: Nine-month pilot RCT with embedded mixed-method perspectives study.

SETTING: 13 hospitals in England.

PATIENTS: Children presenting to emergency departments with suspected infection and shock after 20 mL/kg fluid.

INTERVENTIONS: Patients were randomly allocated (1:1) to further 10 or 20 mL/kg fluid boluses every 15 min for up to 4 hours if still in shock.

MAIN OUTCOME MEASURES: These were based on progression criteria, including recruitment and retention, protocol adherence, separation, potential trial outcome measures, and parent and staff perspectives.

RESULTS: Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were delivered per protocol in the 10 mL/kg arm and 55% in the 20 mL/kg arm. The volume of study bolus fluid after 4 hours was 44% lower in the 10 mL/kg group (mean 14.5 vs 27.5 mL/kg). The Paediatric Index of Mortality-2 score was 2.1 (IQR 1.6-2.7) in the 10 mL/kg group and 2.0 (IQR 1.6-2.5) in the 20 mL/kg group. There were no deaths. Length of hospital stay, paediatric intensive care unit (PICU) admissions and PICU-free days at 30 days did not differ significantly between the groups. In the perspectives study, the trial was generally supported, although some problems with protocol adherence were described.

CONCLUSIONS: Participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK.


Original languageEnglish
Pages (from-to)426-431
Number of pages6
JournalArchives of Disease in Childhood
Issue number5
Publication statusPublished - May 2019


  • Child
  • Child, Preschool
  • Clinical Protocols
  • Emergency Service, Hospital
  • Feasibility Studies
  • Female
  • Fluid Therapy/adverse effects
  • Guideline Adherence
  • Humans
  • Infant
  • Intensive Care Units, Pediatric/statistics & numerical data
  • Length of Stay/statistics & numerical data
  • Male
  • Outcome Assessment, Health Care/methods
  • Patient Admission/statistics & numerical data
  • Pilot Projects
  • Resuscitation/methods
  • Shock, Septic/therapy


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