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 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2018 |
|---|---|
| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
|---|---|
| Enthalten in: |
Trials - 19(2018), 1 vom: 11. Jan., Seite 33 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Baker, Tim [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Blood Glucose |
|---|
| Anmerkungen: |
Date Completed 19.02.2019 Date Revised 10.12.2019 published: Electronic ClinicalTrials.gov: NCT02989675 Citation Status MEDLINE |
|---|
| doi: |
10.1186/s13063-017-2411-8 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM279880790 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM279880790 | ||
| 003 | DE-627 | ||
| 005 | 20231225024046.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2018 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s13063-017-2411-8 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0932.xml |
| 035 | |a (DE-627)NLM279880790 | ||
| 035 | |a (NLM)29325595 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Baker, Tim |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial) |b study protocol for a randomised controlled trial |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 19.02.2019 | ||
| 500 | |a Date Revised 10.12.2019 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02989675 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, NCT02989675 . Registered on 5 December 2016 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Critical care | |
| 650 | 4 | |a Emergency medicine | |
| 650 | 4 | |a Hypoglycaemia | |
| 650 | 4 | |a Paediatrics | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 650 | 7 | |a Glucose |2 NLM | |
| 650 | 7 | |a IY9XDZ35W2 |2 NLM | |
| 700 | 1 | |a Dube, Queen |e verfasserin |4 aut | |
| 700 | 1 | |a Langton, Josephine |e verfasserin |4 aut | |
| 700 | 1 | |a Hildenwall, Helena |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Trials |d 2006 |g 19(2018), 1 vom: 11. Jan., Seite 33 |w (DE-627)NLM161320430 |x 1745-6215 |7 nnns |
| 773 | 1 | 8 | |g volume:19 |g year:2018 |g number:1 |g day:11 |g month:01 |g pages:33 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s13063-017-2411-8 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 19 |j 2018 |e 1 |b 11 |c 01 |h 33 | ||