Restricted fluid bolus volume in early septic shock: results of the Fluids in Shock pilot trial. Issue 5 (16th May 2019)

• Record Type: Journal Article
• Authors: Inwald, David Philip; Canter, Ruth; Woolfall, Kerry; Mouncey, Paul; Zenasni, Zohra; O'Hara, Caitlin; Carter, Anjali; Jones, Nicola; Lyttle, Mark D; Nadel, Simon; Peters, Mark J; Harrison, David A; Rowan, Kathryn M
• Is Part Of: Archives of disease in childhood. Volume 104:Issue 5(2019)
• Page Start: 426
• Publication Date: 2019-05-16
• Subjects: general paediatrics -- intensive care -- accident & emergency -- resuscitation -- infectious diseases; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/archdischild-2018-314924
• Languages: English
• ISSNs: 0003-9888

Abstract

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 Results: Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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