Evidence map›Paper›PMID 30087153›Full record

Trial reportArchives of disease in childhood2019

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

David Philip Inwald, Ruth Canter, Kerry Woolfall, Paul Mouncey, Zohra Zenasni, Caitlin O'Hara, Anjali Carter, Nicola Jones, Mark D Lyttle, Simon Nadel and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of disease in childhood, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06478797 (Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department), which is not on this map. Cited by 37 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06478797 phase2unknown statusnot on this mapstarted 2024, after this paper: background citation

Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)

TypeinterventionalSponsorNATALIA LOPERA MUNERARan2024 to 2025Enrolled40ConditionsSepsisArmsFluid, Adrenalin
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: a pilot randomized controlled trial (REDUCE-1).Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2026
    Trial
  7. Trial
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  9. Trial
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  11. Trial
  12. Proteomic profiling and pathway analyses reveal molecular signatures and immune networks in pediatric sepsis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
    Article
  13. Early inotropic support without fluid bolusWorld journal of clinical pediatrics · 2026
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Fluid bolus therapy in pediatric sepsis: a narrative review.European journal of medical research · 2022
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

David Philip InwaldPaediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare London NHS Trust, London, UK.
Ruth CanterClinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
Kerry WoolfallDepartment of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.
Paul MounceyClinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
Zohra ZenasniClinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
Caitlin O'HaraDepartment of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.
Anjali CarterParent representative.
Nicola JonesParent representative.
Mark D LyttleFaculty of Health and Applied Sciences, University of the West of England, Bristol, UK.ORCID 0000-0002-8634-7210
Simon NadelPaediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare London NHS Trust, London, UK.
Mark J PetersRespiratory, Critical Care and Anaesthesia Section, Institute of Child Health, University College London Great Ormond Street, London, UK.
David A HarrisonClinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
Kathryn M RowanClinical Trials Unit, Intensive Care National Audit & Research Centre, London, UK.
PERUKI (Paediatric Emergency Research in the UK and Ireland) and PICS SG (Paediatric Intensive Care Society Study Group)

Funding

Department of Health HTA/13/04/105Department of Health HTA/15/44/01
6 · The paper itself

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. PATIENTS: Children 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 NUMBER: ISRCTN15244462.

Indexed as

ChildChild, PreschoolClinical ProtocolsEmergency Service, HospitalFeasibility StudiesFemaleFluid TherapyGuideline AdherenceHumansInfantIntensive Care Units, PediatricLength of StayMaleOutcome Assessment, Health CarePatient AdmissionPilot Projectsaccident & emergencygeneral paediatricsinfectious diseasesintensive careresuscitation

Identifiers

PMID30087153
PMCPMC6557227

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.