Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved]
Background: The World Health Organization (WHO) rehydration management guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been formally evaluated in a clinical trial. A recent audit of outcome of AGE...
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doaj-aaa057982ab64b37b7a464562835ce8e2020-11-24T22:54:17ZengWellcomeWellcome Open Research2398-502X2017-08-01210.12688/wellcomeopenres.12261.113274Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved]Kirsty A. Houston0Jack G. Gibb1Ayub Mpoya2Nchafatso Obonyo3Peter Olupot-Olupot4Margeret Nakuya5Jennifer A Evans6Elizabeth C George7Diana M Gibb8Kathryn Maitland9Department of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College London, London, UKDepartment of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College London, London, UKKEMRI-Wellcome Trust Research Programme, Kilifi, KenyaKEMRI-Wellcome Trust Research Programme, Kilifi, KenyaMbale Clinical Research Institute, Mbale, UgandaSoroti Regional Referral Hospital, Soroti, UgandaDepartment of Paediatrics , University Hospital of Wales, Cardiff, UKMedical Research Council (MRC) Clinical Trials Unit, University College London, London, UKMedical Research Council (MRC) Clinical Trials Unit, University College London, London, UKDepartment of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College London, London, UKBackground: The World Health Organization (WHO) rehydration management guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been formally evaluated in a clinical trial. A recent audit of outcome of AGE at Kilifi County Hospital, Kenya noted that 10% of children required high dependency care (20% mortality) and a number developed fluid-related complications. The fluid resuscitation trial, FEAST, conducted in African children with severe febrile illness, demonstrated higher mortality with fluid bolus therapy and raised concerns regarding the safety of rapid intravenous rehydration therapy. Those findings warrant a detailed physiological study of children’s responses to rehydration therapy incorporating quantification of myocardial performance and haemodynamic changes. Methods: GASTRO is a multi-centre, unblinded Phase II randomised controlled trial of 120 children aged 2 months to 12 years admitted to hospital with severe dehydration secondary to AGE. Children with severe malnutrition, chronic diarrhoea and congenital/rheumatic heart disease are excluded. Children will be enrolled over 18 months in 3 centres in Kenya and Uganda and followed until 7 days post-discharge. The trial will randomise children 1:1 to standard rapid rehydration using Ringers Lactate (WHO plan ‘C’ – 100mls/kg over 3-6 hours according to age, plus additional 0.9% saline boluses for children presenting in shock) or to a slower rehydration regimen (100mls/kg given over 8 hours and without the addition of fluid boluses). Enrolment started in November 2016 and is on-going. Primary outcome is frequency of adverse events, particularly related to cardiovascular compromise and neurological sequelae. Secondary outcomes focus on clinical, biochemical, and physiological measures related to assessment of severity of dehydration, and response to treatment by intravenous rehydration. Discussion: Results from this pilot will contribute to generating robust definitions of outcomes (in particular for non-mortality endpoints) for a larger Phase III trial.https://wellcomeopenresearch.org/articles/2-62/v1Global HealthPediatric Infectious Diseases |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kirsty A. Houston Jack G. Gibb Ayub Mpoya Nchafatso Obonyo Peter Olupot-Olupot Margeret Nakuya Jennifer A Evans Elizabeth C George Diana M Gibb Kathryn Maitland |
spellingShingle |
Kirsty A. Houston Jack G. Gibb Ayub Mpoya Nchafatso Obonyo Peter Olupot-Olupot Margeret Nakuya Jennifer A Evans Elizabeth C George Diana M Gibb Kathryn Maitland Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] Wellcome Open Research Global Health Pediatric Infectious Diseases |
author_facet |
Kirsty A. Houston Jack G. Gibb Ayub Mpoya Nchafatso Obonyo Peter Olupot-Olupot Margeret Nakuya Jennifer A Evans Elizabeth C George Diana M Gibb Kathryn Maitland |
author_sort |
Kirsty A. Houston |
title |
Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] |
title_short |
Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] |
title_full |
Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] |
title_fullStr |
Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] |
title_full_unstemmed |
Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration [version 1; referees: 2 approved] |
title_sort |
gastroenteritis aggressive versus slow treatment for rehydration (gastro). a pilot rehydration study for severe dehydration: who plan c versus slower rehydration [version 1; referees: 2 approved] |
publisher |
Wellcome |
series |
Wellcome Open Research |
issn |
2398-502X |
publishDate |
2017-08-01 |
description |
Background: The World Health Organization (WHO) rehydration management guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been formally evaluated in a clinical trial. A recent audit of outcome of AGE at Kilifi County Hospital, Kenya noted that 10% of children required high dependency care (20% mortality) and a number developed fluid-related complications. The fluid resuscitation trial, FEAST, conducted in African children with severe febrile illness, demonstrated higher mortality with fluid bolus therapy and raised concerns regarding the safety of rapid intravenous rehydration therapy. Those findings warrant a detailed physiological study of children’s responses to rehydration therapy incorporating quantification of myocardial performance and haemodynamic changes. Methods: GASTRO is a multi-centre, unblinded Phase II randomised controlled trial of 120 children aged 2 months to 12 years admitted to hospital with severe dehydration secondary to AGE. Children with severe malnutrition, chronic diarrhoea and congenital/rheumatic heart disease are excluded. Children will be enrolled over 18 months in 3 centres in Kenya and Uganda and followed until 7 days post-discharge. The trial will randomise children 1:1 to standard rapid rehydration using Ringers Lactate (WHO plan ‘C’ – 100mls/kg over 3-6 hours according to age, plus additional 0.9% saline boluses for children presenting in shock) or to a slower rehydration regimen (100mls/kg given over 8 hours and without the addition of fluid boluses). Enrolment started in November 2016 and is on-going. Primary outcome is frequency of adverse events, particularly related to cardiovascular compromise and neurological sequelae. Secondary outcomes focus on clinical, biochemical, and physiological measures related to assessment of severity of dehydration, and response to treatment by intravenous rehydration. Discussion: Results from this pilot will contribute to generating robust definitions of outcomes (in particular for non-mortality endpoints) for a larger Phase III trial. |
topic |
Global Health Pediatric Infectious Diseases |
url |
https://wellcomeopenresearch.org/articles/2-62/v1 |
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