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RESULTS: Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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.
Original language | English |
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Pages (from-to) | 426-431 |
Number of pages | 6 |
Journal | Archives of Disease in Childhood |
Volume | 104 |
Issue number | 5 |
DOIs | |
Publication status | Published - May 2019 |
Keywords
- 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