Restricted fluid bolus volume in early septic shock: results of the Fluids in Shock pilot trial.
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
accident & emergency
general paediatrics
infectious diseases
intensive care
resuscitation
Journal
Archives of disease in childhood
ISSN: 1468-2044
Titre abrégé: Arch Dis Child
Pays: England
ID NLM: 0372434
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
06
02
2018
revised:
10
07
2018
accepted:
15
07
2018
pubmed:
9
8
2018
medline:
24
1
2020
entrez:
9
8
2018
Statut:
ppublish
Résumé
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). Nine-month pilot RCT with embedded mixed-method perspectives study. 13 hospitals in England. Children presenting to emergency departments with suspected infection and shock after 20 mL/kg fluid. 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. These were based on progression criteria, including recruitment and retention, protocol adherence, separation, potential trial outcome measures, and parent and staff perspectives. Seventy-five participants were randomised; two were withdrawn. 23 (59%) of 39 in the 10 mL/kg arm and 25 (74%) of 34 in the 20 mL/kg arm required a single trial bolus before the shock resolved. 79% of boluses were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. Participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK. ISRCTN15244462.
Identifiants
pubmed: 30087153
pii: archdischild-2018-314924
doi: 10.1136/archdischild-2018-314924
pmc: PMC6557227
doi:
Banques de données
ISRCTN
['ISRCTN15244462']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
426-431Subventions
Organisme : Department of Health
ID : HTA/13/04/105
Pays : United Kingdom
Organisme : Department of Health
ID : HTA/15/44/01
Pays : United Kingdom
Commentaires et corrections
Type : CommentIn
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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