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

Abstract

ObjectiveTo 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).DesignNine-month pilot RCT with embedded mixed-method perspectives study.Setting13 hospitals in England.PatientsChildren presenting to emergency departments with suspected infection and shock after 20 mL/kg fluid.InterventionsPatients 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 measuresThese were based on progression criteria, including recruitment and retention, protocol adherence, separation, potential trial outcome measures, and parent and staff perspectives.ResultsSeventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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.ConclusionsParticipants were not as unwell as expected. A larger trial is not feasible in its current design in the UK.Trial registration numberISRCTN15244462.

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study

“…These criteria set an appropriately high bar and, thus, EFIC studies have been uncommon to date in children. However, several EFIC‐based studies have been successfully carried out in the United States and, using a related ethical design, in Europe, Canada, and Australia . For this study of two efficacious resuscitation fluids, enrollment with EFIC was approved by our IRB, endorsed by the FDA through our IND application, and proved acceptable to patients/families and clinicians.…”

Can they stomach it? Parent and practitioner acceptability of a trial comparing Gastric Residual Volume measurement versus no Gastric Residual Volume in UK NNU and PICU’s

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Quality of life in congenital heart disease

“…2 The wider relevance of these findings has been hotly debated. 2 The Fluids in Shock study is an English pilot study 3 ; it randomised 75 children presenting to emergency departments with clinical sepsis and shock persisting after a fluid bolus of 20 mL/kg, to further fluid boluses of either 10 or 20 mL/kg every 15 min for up to 4 h if still shocked. 3 Participants were not as unwell as expected, there were no deaths and the authors concluded a larger UK trial was not feasible.…”

“…2 The Fluids in Shock study is an English pilot study 3 ; it randomised 75 children presenting to emergency departments with clinical sepsis and shock persisting after a fluid bolus of 20 mL/kg, to further fluid boluses of either 10 or 20 mL/kg every 15 min for up to 4 h if still shocked. 3 Participants were not as unwell as expected, there were no deaths and the authors concluded a larger UK trial was not feasible. However, an accompanying editorial 2 points out that the lower dose of 10 mL/kg compared with 20 mL/kg was associated with a paediatric intensive care unit admission rate of 26 versus 32%, median paediatric intensive care unit stay of 45 h (interquartile range 18-143) versus 119 h (interquartile range 52-228), mechanical ventilation 11 versus 25% and use of inotropes 2.8 versus 15.6%, and argues, after an initial 20 mL/kg bolus, for a more conservative guideline of giving 10 mL/kg every 15 min.…”