High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of
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LETTER
Open Access
High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial Luis Patricio Maskin1,2* , Gabriel Leonardo Olarte3, Fernando Palizas Jr4, Agostina E. Velo1, María Fernanda Lurbet1, Ignacio Bonelli1, Natalio D. Baredes3 and Pablo Oscar Rodríguez1,2*
Abstract Objectives: The aim of this study is to explore the effectiveness and safety of high dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to SARS-Cov-2 pneumonia. Trial design: Multicentre, randomized clinical trial, controlled, open label, parallel group, to evaluate the effectiveness and safety of high dose dexamethasone in adult patients with confirmed COVID-19, with Acute Respiratory Distress Syndrome. Participants: We will include patients with SARS-Cov-2 pneumonia who develop acute respiratory distress syndrome, in several intensive care units (ICU) in Buenos Aires, Argentina (CEMIC, Clinica Bazterrica, Sanatorio Sagrado Corazon) Inclusion criteria: – Men and women, age ≥ 18 years old. – Confirmed diagnosis of SARS-CoV-2 infection, by RT-PCR. – Diagnosis of Acute Respiratory Distress Syndrome (hypoxemic respiratory failure not explained by cardiac disease + PaO2/FiO2 ratio < 300 with a Positive End-Expiratory Pressure ≥ 5 cm H2O + bilateral pulmonary infiltrates) – Length of mechanical ventilation of at least 72 hours – Informed consent (next of kin / legal guardian) Exclusion criteria: – Pregnant or breast-feeding women. – Terminal disease (advanced cancer; under palliative care; cardiovascular, respiratory, or renal disease with a life (Continued on next page)
* Correspondence: [email protected]; [email protected] 1 Intensive Care Unit, CEMIC, Buenos Aires, Argentina Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This 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/. The Creative Commons Public Domain Dedication waiver (http://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.
Maskin et al. Trials
(2020) 21:743
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