Evidence map›Paper›PMID 29325595›Full record

ArticleTrials2018

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.

Tim Baker, Queen Dube, Josephine Langton, Helena Hildenwall

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02989675 (SugarFACT - Sugar Requirements For African Children Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
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.

NCT02989675 naterminatednot on this map

SugarFACT - Sugar Requirements For African Children Trial

TypeinterventionalSponsorHelena HildenwallRan2016 to 2019Enrolled410ConditionsHypoglycemia Non Diabetics, Emergencies, Pediatric ALL, Critical IllnessArms10% dextrose
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Tim BakerGlobal Health - Health System and Policy Research Group, Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
Queen DubeDepartment of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.
Josephine LangtonDepartment of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.
Helena HildenwallGlobal Health - Health System and Policy Research Group, Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden. Helena.Hildenwall@ki.se.ORCID http://orcid.org/0000-0001-7570-9792
University of Malawi · MWKarolinska University Hospital · SEPublic Health Agency of Sweden · SE

Funding

Vetenskapsrådet 2016-00230Vetenskapsrådet 348-2014-2791
6 · The paper itself

Abstract

backgroundMortality 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.

methodsA 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 registrationClinicalTrials.gov, NCT02989675 . Registered on 5 December 2016.

Indexed as

Blood GlucoseChild, PreschoolCritical IllnessGlucoseHumansHypoglycemiaInfantOutcome Assessment, Health CareRandomized Controlled Trials as TopicBlood GlucoseGlucoseCritical careEmergency medicineHypoglycaemiaPaediatrics

Identifiers

PMID29325595
PMCPMC5765642
OpenAlexW2784097273

What OpenQuestion holds

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LicenceCC BY
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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.