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Part 1: Document Description
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Citation |
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Title: |
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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Identification Number: |
doi:10.7910/DVN/UXTBZP |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2021-08-25 |
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Version: |
1 |
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Bibliographic Citation: |
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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Citation |
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Title: |
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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Identification Number: |
doi:10.7910/DVN/UXTBZP |
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Authoring Entity: |
Houston, Kirsty A. (Department of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College, London, W2 1PG, UK KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Gibb, Jack (Department of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College, London, W2 1PG, UK KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Olupot-Olupot, Peter (Mbale Clinical Research Institute, Pallisa Road, PO Box 291, Mbale, Uganda Mbale Regional Referral Hospital, Pallisa Road, PO Box 291, Mbale, Uganda) |
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Obonyo, Nchafatso (KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Mpoya, Ayub (KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Nakuya, Margaret (Soroti Regional Referral Hospital, PO Box 289, Soroti, Uganda) |
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Muhindo, Rita (Mbale Clinical Research Institute, Pallisa Road, PO Box 291, Mbale, Uganda Mbale Regional Referral Hospital, Pallisa Road, PO Box 291, Mbale, Ugand) |
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Uyoga, Sophie (KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Evans, Jennifer A. (Department of Paediatrics, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, Wales, UK) |
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Connon, Roisin (MRC Clinical Trials Unit at UCL 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK) |
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Gibb, Diana M. (MRC Clinical Trials Unit at UCL 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK) |
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George, Elizabeth C. (MRC Clinical Trials Unit at UCL 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK) |
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Maitland, Kathryn (Department of Paediatrics, Faculty of Medicine, St Mary’s Campus, Norfolk Place, Imperial College, London, W2 1PG, UK KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya) |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Maitland, Kathryn |
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Access Authority: |
The Data Governance Committee |
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Depositor: |
Houston, Kirsty A. |
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Date of Deposit: |
2020-11-30 |
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Holdings Information: |
https://doi.org/10.7910/DVN/UXTBZP |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences |
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Abstract: |
<p>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.</p> <p>The trial was registered at <a href="https://www.isrctn.com/">ISRCTN registry: </a><a href="https://doi.org/10.1186/ISRCTN67518332"> ISRCTN67518332</a>. </p> |
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Kind of Data: |
Clinical Trial |
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Kind of Data: |
Restricted Access |
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Notes: |
<p><strong>Data Access </strong>: Restricted</p> <p>Access to these data requires submission of a formal request for consideration by our Data Governance Committee. </p> <strong>How to request</strong> <ol> <li>Download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a></li> <li> Email completed data request form to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?cc=lmwango@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a> </li> </ol> <p><strong>License</strong>: <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a> </p> |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Citation Requirement: |
<p>Publications based on this data collection should acknowledge this source by means of bibliographic citation.</p> |
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Notes: |
<p>This data is licensed under the <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a> </p> |
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For access to data and more detailed information beyond the metadata and documentation provided, there is a process of managed access requiring submission of a request form for consideration by our Data Governance Committee [<a href="mailto:dgc@kemri-wellcome.org">dgc@kemri-wellcome.org</a> ]. <strong> <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx">Click to download Data Request Form</a></strong> |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Title: |
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-z |
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Identification Number: |
10.1186/s12916-019-1356-z |
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Bibliographic Citation: |
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-z |
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Citation |
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Title: |
Houston, K.A, Gibb, J., Mpoya, A., Obonyo, N., Olupot-Olupot, P., Nakuya, M., Evans, J.A., George, E.C., Gibb, D.M., Maitland, K., 2017. Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration. Wellcome Open Res. 2017;2:62. doi:10.12688/wellcomeopenres.12261.1 |
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Identification Number: |
10.12688/wellcomeopenres.12261.1 |
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Bibliographic Citation: |
Houston, K.A, Gibb, J., Mpoya, A., Obonyo, N., Olupot-Olupot, P., Nakuya, M., Evans, J.A., George, E.C., Gibb, D.M., Maitland, K., 2017. Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration. Wellcome Open Res. 2017;2:62. doi:10.12688/wellcomeopenres.12261.1 |
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File Description--f5006098 |
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File: Baseline.tab |
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Notes: |
UNF:6:re/JVKsqXLaDJtdDgt0oHQ== |
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This file contains data collected during screening and enrollment, and clinical assessment at admission. |
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File Description--f5006094 |
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File: During_Admission.tab |
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Notes: |
UNF:6:GHw8AFkM71T732mYZ6p2ow== |
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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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File Description--f5006099 |
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File: Fluids.tab |
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Notes: |
UNF:6:rijXIl7HAJ0izYEr4i14Eg== |
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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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File Description--f5006096 |
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File: Followup.tab |
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Notes: |
UNF:6:H4GQsFO4xDbgVsJ+mowOhg== |
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This file contains data collected at follow up, 7 days post-discharge. |
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File Description--f5006097 |
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File: Lab_results.tab |
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Notes: |
UNF:6:M4w0/OINuHzEtfPvBkcHWA== |
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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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File Description--f5006095 |
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File: SAE.tab |
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Notes: |
UNF:6:CELIOuVPz8s/zR0UDCZ7HA== |
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This file contains all serious adverse events reported during the trial follow-up. |
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Label: |
Data Dictionary.pdf |
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Text: |
Contains variable descriptions and value labels |
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Notes: |
application/pdf |
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Label: |
GASTRO readme.txt |
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Notes: |
text/plain |
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Label: |
KCH - GASTRO CRF Version 2.pdf |
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Notes: |
application/pdf |