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Arch Dis Child. 2018 Aug 7. pii: archdischild-2018-314924. doi: 10.1136/archdischild-2018-314924. [Epub ahead of print]

Restricted fluid bolus volume in early septic shock: results of the Fluids in Shock pilot trial.

Author information

1
Paediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare London NHS Trust, London, UK.
2
Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
3
Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.
4
Parent representative.
5
Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
6
Emergency Department, Bristol Royal Hospital for Children, Bristol, UK.
7
Respiratory, Critical Care and Anaesthesia Section, Institute of Child Health, University College London Great Ormond Street, London, UK.

Abstract

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Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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:

ISRCTN 15244462.

KEYWORDS:

accident & emergency; general paediatrics; infectious diseases; intensive care; resuscitation

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