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Results Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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.
Trial registration number ISRCTN15244462.
- general paediatrics
- intensive care
- accident & emergency
- infectious diseases
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Contributors The study was conceived by DPI, MJP, MDL, PM, DAH, KW and KMR. AC and NJ provided parental input. The pilot trial was conducted and analysed by PM, RC, ZZ, DAH, KMR and DPI. RC was the trial manager and DPI was the chief investigator. The qualitative work was conducted and analysed by CO’H and KW. The paper was drafted by DPI, RC, PM, DAH and CO’H. All authors read and approved the final manuscript.
Funding This study was funded by the NIHR HTA programme (13/04/105).
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Patient consent Not required.
Ethics approval Health Research Authority (HRA) approval was given (Integrated Research Application System reference number: 195544; London - Stanmore Research Ethics Committee reference number: 16/LO/0854).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The data sets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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