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
Abstract 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 b...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-01-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2411-8 |
| _version_ | 1818175299473375232 |
|---|---|
| author | Tim Baker Queen Dube Josephine Langton Helena Hildenwall |
| author_facet | Tim Baker Queen Dube Josephine Langton Helena Hildenwall |
| author_sort | Tim Baker |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-11T19:58:05Z |
| format | Article |
| id | doaj.art-6aef42f66aea46319ad85dd65378c0b0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T19:58:05Z |
| publishDate | 2018-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6aef42f66aea46319ad85dd65378c0b02022-12-22T00:52:36ZengBMCTrials1745-62152018-01-011911710.1186/s13063-017-2411-8Mortality 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 trialTim Baker0Queen Dube1Josephine Langton2Helena Hildenwall3Global Health – Health System and Policy Research Group, Department of Public Health Sciences, Karolinska InstitutetDepartment of Paediatrics, College of Medicine, University of MalawiDepartment of Paediatrics, College of Medicine, University of MalawiGlobal Health – Health System and Policy Research Group, Department of Public Health Sciences, Karolinska InstitutetAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2411-8HypoglycaemiaCritical carePaediatricsEmergency medicine |
| spellingShingle | Tim Baker Queen Dube Josephine Langton Helena Hildenwall 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 Trials Hypoglycaemia Critical care Paediatrics Emergency medicine |
| 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 | Hypoglycaemia Critical care Paediatrics Emergency medicine |
| url | http://link.springer.com/article/10.1186/s13063-017-2411-8 |
| work_keys_str_mv | AT timbaker mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial AT queendube mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial AT josephinelangton mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial AT helenahildenwall mortalityimpactofanincreasedbloodglucosecutofflevelforhypoglycaemiatreatmentinseverelysickchildreninmalawisugarfacttrialstudyprotocolforarandomisedcontrolledtrial |