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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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29 July 2019 |
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Main ID: |
ISRCTN67518332 |
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Date of registration:
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05/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Gastroenteritis aggressive versus slow treatment for rehydration
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Scientific title:
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Gastroenteritis Aggressive versus Slow Treatment for RehydratiOn (GASTRO): a pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration
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Date of first enrolment:
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01/09/2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN67518332 |
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Study type:
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Interventional |
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Study design:
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A pilot phase II trial comparing slow versus standard (fast) intravenous rehydration of children admitted to hospital with gastroenteritis and severe dehydration (Treatment)
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Phase:
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Phase II
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Kirsty
Houston |
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Address:
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PO Box 230
Clinical Trials Facility
80108
Kilifi
Kenya |
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Telephone:
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Email:
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Affiliation:
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Name:
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Kathryn
Maitland |
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Address:
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PO Box 230
Clinical Trials Facility
80108
Kilifi
Kenya |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children, aged 60 days to 12 years, with acute gastroenteritis (> 3 loose stools/day over a period of <14days) and signs of severe dehydration (as per WHO definition – unable to drink or AVPU 3 seconds.
Exclusion criteria:
1. Severe malnutrition (kwashiorkor or MUAC <11.5cm)
2. Diarrhoea lasting more than 14-days
3. Children with known congenital heart disease (or diagnosed on initial ECHO assessment)
4. Refusal of consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe dehydration secondary to acute gastroenteritis
Digestive System
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Intervention(s)
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Eligible children, whose parents have given consent (or verbal assent with deferred consent), will be randomized in a 1:1 ratio to one of two treatment arms. One arm will receive treatment as per the WHO recommendations, and the other arm will receive a slower rehydration regimen. All children will receive Ringers Lactate (as per WHO recommendations).
WHO Plan ‘C’ arm:
Children in the WHO Plan ‘C’ arm will be assessed for shock. Those who meet WHO criteria for shock will receive up to two 20ml/Kg boluses before starting treatment on Plan C. All children in the WHO Plan ‘C’ arm will receive 30ml/Kg (over 30mins if =1yr, and 1hour if <1yr) and then 70ml/Kg (over 2.5hrs if =1yr, and 5hours if <1yr)
GASTRO Slow Arm
There will be no fluid boluses given to children randomised to the GASTRO Slow Arm (regardless of features of shock). ALL children will receive 100mls/Kg over 8hours, regardless of age.
If the patient has ongoing GI losses then there will be a clinical review and the child may receive one further course of IV fluids as per the arm to which they have been randomized. If losses persist after this, fluids will be titrated as per the individual child’s fluid balance.
Patients will be offered oral fluids throughout the trial but, for the purposes of this trial, all will complete their prescribed intravenous fluid therapy.
Patients will have regular observations and clinical reviews. All patients will be followed up on Day 7 following admission.
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Primary Outcome(s)
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Frequency of fluid related significant adverse events including mortality, development of hypotensive shock, pulmonary oedema and neurological compromise measured using serial clinical and observational assessments at 1, 4, 8, 24 and 48 hours after admission.
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Secondary Outcome(s)
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1. Time to correction of dehydration as measured by the ability to take and retain oral fluids/feeds and who are in neutral or marginally positive fluid balance (both input and output will be measured). This will be deduced from hourly fluid balance charts, nursing records and clinical assessments
2. Time to pass urine and urine output measured by hourly urinary catheter bag volumes
3. Dysnatraemia at 8 hours measured by serum electrolyte sampling at admission, 8 and 24hours
4. Time to tolerate oral feeds as documented on hourly nursing observations
5. Time to discharge
6. Bioelectrical impedence analysis will be performed at 1, 24, 48hours and on day 7 review and will assess hydration status
7. Echocardiography will be performed at 1, 4, 8 and 24hours after admission and will assess cardiovascular responses to intravenous rehydration
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Secondary ID(s)
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16IC3388 and KEMRI/SERU/CGMR-C.053/3299
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Source(s) of Monetary Support
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Imperial College London
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Ethics review
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Status:
Approval date:
Contact:
1. Imperial College (ICREC) - Original approval 18/08/2016, Ref 16IC3388, Amendment approved 16/09/2016
2. KEMRI SERU - Original approval 16/08/2016, Ref 053/3299, Amendment approved 20/10/2016
3. Poisons and Pharmaceuticals Board - Original approval 20/09/2016 (application made with amended protocol)
4. MRHREC - Original approval 28/11/2016
5. UNCST - awaited
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/01/2018 |
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URL:
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