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

Arch Dis Child. 2019 May;104(5):426-431. doi: 10.1136/archdischild-2018-314924. Epub 2018 Aug 7.

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Results: Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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: ISRCTN15244462.

Keywords: accident & emergency; general paediatrics; infectious diseases; intensive care; resuscitation.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child, Preschool
  • Clinical Protocols
  • Emergency Service, Hospital
  • Feasibility Studies
  • Female
  • Fluid Therapy / adverse effects
  • Fluid Therapy / methods*
  • 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*

Associated data

  • ISRCTN/ISRCTN15244462