Cargando…

Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial

BACKGROUND: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies, such as maintaining normal glucose and electrolyte balances, has been give...

Descripción completa

Detalles Bibliográficos
Autores principales: Baker, Tim, Dube, Queen, Langton, Josephine, Hildenwall, Helena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765642/
https://www.ncbi.nlm.nih.gov/pubmed/29325595
http://dx.doi.org/10.1186/s13063-017-2411-8
_version_ 1783292264084144128
author Baker, Tim
Dube, Queen
Langton, Josephine
Hildenwall, Helena
author_facet Baker, Tim
Dube, Queen
Langton, Josephine
Hildenwall, Helena
author_sort Baker, Tim
collection PubMed
description BACKGROUND: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies, such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level < 2.5 mmol/L in a well-nourished child. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5–5.0 mmol/L. The reason for increased mortality rates is not fully understood. This proposal is for a randomised controlled trial to determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia. METHODS: A total of 1266 severely ill children (age range = 1 month – 5 years) admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi with blood glucose in the range of 2.5–5.0 mmol/L will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5 mL/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death. DISCUSSION: The first patient was enrolled in December 2016 and the expected trial deadline is January 2019. This study is the first to evaluate the benefits of increased dextrose administration in children presenting to hospital with low-glycaemia. The findings will inform national and international policies and guidelines for the management of children with blood sugar abnormalities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02989675. Registered on 5 December 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-017-2411-8) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5765642
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-57656422018-01-17 Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial Baker, Tim Dube, Queen Langton, Josephine Hildenwall, Helena Trials Study Protocol BACKGROUND: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies, such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level < 2.5 mmol/L in a well-nourished child. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5–5.0 mmol/L. The reason for increased mortality rates is not fully understood. This proposal is for a randomised controlled trial to determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia. METHODS: A total of 1266 severely ill children (age range = 1 month – 5 years) admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi with blood glucose in the range of 2.5–5.0 mmol/L will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5 mL/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death. DISCUSSION: The first patient was enrolled in December 2016 and the expected trial deadline is January 2019. This study is the first to evaluate the benefits of increased dextrose administration in children presenting to hospital with low-glycaemia. The findings will inform national and international policies and guidelines for the management of children with blood sugar abnormalities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02989675. Registered on 5 December 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-017-2411-8) contains supplementary material, which is available to authorized users. BioMed Central 2018-01-11 /pmc/articles/PMC5765642/ /pubmed/29325595 http://dx.doi.org/10.1186/s13063-017-2411-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Baker, Tim
Dube, Queen
Langton, Josephine
Hildenwall, Helena
Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title_full Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title_fullStr Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title_full_unstemmed Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title_short Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
title_sort mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in malawi (sugarfact trial): study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765642/
https://www.ncbi.nlm.nih.gov/pubmed/29325595
http://dx.doi.org/10.1186/s13063-017-2411-8
work_keys_str_mv AT bakertim mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial
AT dubequeen mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial
AT langtonjosephine mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial
AT hildenwallhelena mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial