Gastroenteritis aggressive versus slow treatment for rehydration

Gastroenteritis Aggressive versus Slow Treatment for RehydratiOn (GASTRO): a pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67518332

Enrollment

120

Registered

2016-09-05

Start date

2016-09-01

Completion date

Unknown

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe dehydration secondary to acute gastroenteritis Digestive System

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children, aged 60 days to 12 years, with acute gastroenteritis (> 3 loose stools/day over a period of 3 seconds.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Kenya

Contacts

Public ContactKirsty Houston

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026