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A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials

BACKGROUND: Dengue is a neglected tropical disease, for which no therapeutic agents have shown clinical efficacy to date. Clinical trials have used strikingly variable clinical endpoints, which hampers reproducibility and comparability of findings. We investigated a delta modified Sequential Organ F...

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Autores principales: McBride, Angela, Vuong, Nguyen Lam, Van Hao, Nguyen, Huy, Nguyen Quang, Chanh, Ho Quang, Chau, Nguyen Thi Xuan, Nguyet, Nguyen Minh, Ming, Damien K., Ngoc, Nguyen Thanh, Nhat, Phung Tran Huy, Phong, Nguyen Thanh, Tai, Luong Thi Hue, Tho, Phan Vinh, Trung, Dinh The, Tam, Dong Thi Hoai, Trieu, Huynh Trung, Geskus, Ronald Bertus, Llewelyn, Martin J., Thwaites, C. Louise, Yacoub, Sophie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441074/
https://www.ncbi.nlm.nih.gov/pubmed/36057771
http://dx.doi.org/10.1186/s12879-022-07705-8
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author McBride, Angela
Vuong, Nguyen Lam
Van Hao, Nguyen
Huy, Nguyen Quang
Chanh, Ho Quang
Chau, Nguyen Thi Xuan
Nguyet, Nguyen Minh
Ming, Damien K.
Ngoc, Nguyen Thanh
Nhat, Phung Tran Huy
Phong, Nguyen Thanh
Tai, Luong Thi Hue
Tho, Phan Vinh
Trung, Dinh The
Tam, Dong Thi Hoai
Trieu, Huynh Trung
Geskus, Ronald Bertus
Llewelyn, Martin J.
Thwaites, C. Louise
Yacoub, Sophie
author_facet McBride, Angela
Vuong, Nguyen Lam
Van Hao, Nguyen
Huy, Nguyen Quang
Chanh, Ho Quang
Chau, Nguyen Thi Xuan
Nguyet, Nguyen Minh
Ming, Damien K.
Ngoc, Nguyen Thanh
Nhat, Phung Tran Huy
Phong, Nguyen Thanh
Tai, Luong Thi Hue
Tho, Phan Vinh
Trung, Dinh The
Tam, Dong Thi Hoai
Trieu, Huynh Trung
Geskus, Ronald Bertus
Llewelyn, Martin J.
Thwaites, C. Louise
Yacoub, Sophie
author_sort McBride, Angela
collection PubMed
description BACKGROUND: Dengue is a neglected tropical disease, for which no therapeutic agents have shown clinical efficacy to date. Clinical trials have used strikingly variable clinical endpoints, which hampers reproducibility and comparability of findings. We investigated a delta modified Sequential Organ Failure Assessment (delta mSOFA) score as a uniform composite clinical endpoint for use in clinical trials investigating therapeutics for moderate and severe dengue. METHODS: We developed a modified SOFA score for dengue, measured and evaluated its performance at baseline and 48 h after enrolment in a prospective observational cohort of 124 adults admitted to a tertiary referral hospital in Vietnam with dengue shock. The modified SOFA score included pulse pressure in the cardiovascular component. Binary logistic regression, cox proportional hazard and linear regression models were used to estimate association between mSOFA, delta mSOFA and clinical outcomes. RESULTS: The analysis included 124 adults with dengue shock. 29 (23.4%) patients required ICU admission for organ support or due to persistent haemodynamic instability: 9/124 (7.3%) required mechanical ventilation, 8/124 (6.5%) required vasopressors, 6/124 (4.8%) required haemofiltration and 5/124 (4.0%) patients died. In univariate analyses, higher baseline and delta (48 h) mSOFA score for dengue were associated with admission to ICU, requirement for organ support and mortality, duration of ICU and hospital admission and IV fluid use. CONCLUSIONS: The baseline and delta mSOFA scores for dengue performed well to discriminate patients with dengue shock by clinical outcomes, including duration of ICU and hospital admission, requirement for organ support and death. We plan to use delta mSOFA as the primary endpoint in an upcoming host-directed therapeutic trial and investigate the performance of this score in other phenotypes of severe dengue in adults and children. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-022-07705-8.
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spelling pubmed-94410742022-09-05 A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials McBride, Angela Vuong, Nguyen Lam Van Hao, Nguyen Huy, Nguyen Quang Chanh, Ho Quang Chau, Nguyen Thi Xuan Nguyet, Nguyen Minh Ming, Damien K. Ngoc, Nguyen Thanh Nhat, Phung Tran Huy Phong, Nguyen Thanh Tai, Luong Thi Hue Tho, Phan Vinh Trung, Dinh The Tam, Dong Thi Hoai Trieu, Huynh Trung Geskus, Ronald Bertus Llewelyn, Martin J. Thwaites, C. Louise Yacoub, Sophie BMC Infect Dis Research BACKGROUND: Dengue is a neglected tropical disease, for which no therapeutic agents have shown clinical efficacy to date. Clinical trials have used strikingly variable clinical endpoints, which hampers reproducibility and comparability of findings. We investigated a delta modified Sequential Organ Failure Assessment (delta mSOFA) score as a uniform composite clinical endpoint for use in clinical trials investigating therapeutics for moderate and severe dengue. METHODS: We developed a modified SOFA score for dengue, measured and evaluated its performance at baseline and 48 h after enrolment in a prospective observational cohort of 124 adults admitted to a tertiary referral hospital in Vietnam with dengue shock. The modified SOFA score included pulse pressure in the cardiovascular component. Binary logistic regression, cox proportional hazard and linear regression models were used to estimate association between mSOFA, delta mSOFA and clinical outcomes. RESULTS: The analysis included 124 adults with dengue shock. 29 (23.4%) patients required ICU admission for organ support or due to persistent haemodynamic instability: 9/124 (7.3%) required mechanical ventilation, 8/124 (6.5%) required vasopressors, 6/124 (4.8%) required haemofiltration and 5/124 (4.0%) patients died. In univariate analyses, higher baseline and delta (48 h) mSOFA score for dengue were associated with admission to ICU, requirement for organ support and mortality, duration of ICU and hospital admission and IV fluid use. CONCLUSIONS: The baseline and delta mSOFA scores for dengue performed well to discriminate patients with dengue shock by clinical outcomes, including duration of ICU and hospital admission, requirement for organ support and death. We plan to use delta mSOFA as the primary endpoint in an upcoming host-directed therapeutic trial and investigate the performance of this score in other phenotypes of severe dengue in adults and children. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-022-07705-8. BioMed Central 2022-09-03 /pmc/articles/PMC9441074/ /pubmed/36057771 http://dx.doi.org/10.1186/s12879-022-07705-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
McBride, Angela
Vuong, Nguyen Lam
Van Hao, Nguyen
Huy, Nguyen Quang
Chanh, Ho Quang
Chau, Nguyen Thi Xuan
Nguyet, Nguyen Minh
Ming, Damien K.
Ngoc, Nguyen Thanh
Nhat, Phung Tran Huy
Phong, Nguyen Thanh
Tai, Luong Thi Hue
Tho, Phan Vinh
Trung, Dinh The
Tam, Dong Thi Hoai
Trieu, Huynh Trung
Geskus, Ronald Bertus
Llewelyn, Martin J.
Thwaites, C. Louise
Yacoub, Sophie
A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title_full A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title_fullStr A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title_full_unstemmed A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title_short A modified Sequential Organ Failure Assessment score for dengue: development, evaluation and proposal for use in clinical trials
title_sort modified sequential organ failure assessment score for dengue: development, evaluation and proposal for use in clinical trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441074/
https://www.ncbi.nlm.nih.gov/pubmed/36057771
http://dx.doi.org/10.1186/s12879-022-07705-8
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