Data for: Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration

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Data for: Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration
Houston, Kirsty A.; Gibb, Jack; Olupot-Olupot, Peter; Obonyo, Nchafatso; Mpoya, Ayub; Nakuya, Margaret; Muhindo, Rita; Uyoga, Sophie; Evans, Jennifer A.; Connon, Roisin; Gibb, Diana M.; George, Elizabeth C.; Maitland, Kathryn, 2021, "Data for: Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration", https://doi.org/10.7910/DVN/UXTBZP, Harvard Dataverse, V1, UNF:6:tTt8SmeSoimg6d2G7FoYfA== [fileUNF]
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Description

A multi-centre open-label phase II randomised controlled trial evaluated two rehydration strategies in 122 Ugandan/Kenyan children aged 60 days to 12 years with severe dehydration secondary to gastroenteritis. We compared the safety and efficacy of standard rapid rehydration using Ringer’s lactate (100 ml/kg over 3 h (6 h if < 1 year), incorporating 0.9% saline boluses for children with shock (plan C) versus slower rehydration: 100 ml/kg Ringer’s lactate over 8 h (all ages) without boluses (slow: experimental). The primary outcome was the frequency of serious adverse events (SAE) within 48 h including cardiovascular, respiratory and neurological complications. Secondary outcomes included clinical, biochemical and physiological measures of response to treatment by intravenous rehydration.

The trial was registered at ISRCTN registry: ISRCTN67518332.

Subject Medicine, Health and Life Sciences
Related Publication Houston, K.A., Gibb, J., Olupot-Olupot, P. et al. Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration. BMC Med 17, 122 (2019). https://doi.org/10.1186/s12916-019-1356-zdoi: 10.1186/s12916-019-1356-z
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Data Dictionary.pdf
Data Dictionary.pdf
Adobe PDF - 389.8 KB
Published Aug 25, 2021
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MD5: 414e032b94b9b3c8a857f1d4998af6e5
Contains variable descriptions and value labels
DocumentationVariable Codebook/Data Dictionary
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GASTRO readme.txt
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Published Aug 25, 2021
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MD5: 775d1e859d830d798c00e74700da17fb
DocumentationReadme
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KCH - GASTRO CRF Version 2.pdf
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Published Aug 25, 2021
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MD5: ca83b7ba2369a9e983ef46ccad12c3df
DocumentationCase Report Form (CRF)
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Baseline.tab
Tabular Data - 27.8 KB
Published Aug 25, 2021
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58 Variables, 122 Observations UNF:6:re/JVKsqXLaDJtdDgt0oHQ==
This file contains data collected during screening and enrollment, and clinical assessment at admission.
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During_Admission.tab
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Published Aug 25, 2021
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417 Variables, 122 Observations UNF:6:GHw8AFkM71T732mYZ6p2ow==
This file contains data from clinical reviews during admission (at 1, 4, 8, 12, 24 and 48 hours after starting fluids) and observations (at 0, 30, 60, 90, 120, 180 minutes and 4, 8, 12, 24 hours after starting fluids), anthropometry measurements (taken daily from admission to day 4) and information collected at discharge.
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Fluids.tab
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Published Aug 25, 2021
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49 Variables, 3416 Observations UNF:6:rijXIl7HAJ0izYEr4i14Eg==
This file is in long format and contains the times rehydration and bolus fluids were given, times of oral intake and urine output, and the fluid prescriptions.
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Followup.tab
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Published Aug 25, 2021
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37 Variables, 115 Observations UNF:6:H4GQsFO4xDbgVsJ+mowOhg==
This file contains data collected at follow up, 7 days post-discharge.
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Lab_results.tab
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188 Variables, 122 Observations UNF:6:M4w0/OINuHzEtfPvBkcHWA==
This file contains results from blood and urine tests taken at admission, 8 hours, 24 hours, and day 7 post-discharge.
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SAE.tab
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Published Aug 25, 2021
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57 Variables, 6 Observations UNF:6:CELIOuVPz8s/zR0UDCZ7HA==
This file contains all serious adverse events reported during the trial follow-up.
DataSTATA v15
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