LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 4 of total 4

Search options

  1. Article ; Online: COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial.

    Tomazini, Bruno Martins / Maia, Israel S. / Bueno, Flavia R. / Silva, Maria Vitoria A. O. / Baldassare, Franca P. / Costa, Eduardo Leite V. / Moura, Ricardo A. B. / Honorato, Michele / Costa, Andre N. / Cavalcanti, Alexandre B. / Rosa, Regis / Avezum, Alvaro / Veiga, Viviane C. / Lopes, Renato D. / Damiani, Lucas P. / Machado, Flavia R. / Berwanger, Otavio / Azevedo, Luciano C. P.

    medRxiv

    Abstract: OBJECTIVES: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV2 infection (Coronavirus disease 2019 - COVID-19) is viral ... ...

    Abstract OBJECTIVES: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV2 infection (Coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop Acute Respiratory Distress Syndrome (ARDS). Several clinical trials evaluated the role of corticosteroids in non-COVID-19 ARDS with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe ARDS due to confirmed or probable COVID-19. METHODS: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48h before randomization) moderate or severe ARDS, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (intervention group) or standard treatment without dexamethasone (control group). Patients in the intervention group will receive dexamethasone 20mg IV once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until Intensive Care Unit (ICU) discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment (SOFA) Score evaluation at 48h, 72h and 7 days and ICU-free days within 28. ETHICS AND DISSEMINATION: This trial was approved by the Brazilian National Committee of Ethics in Research (Comissão Nacional de Ética em Pesquisa - CONEP) and National Health Surveillance Agency (ANVISA). An independent data monitoring committee will perform interim analyses and evaluate adverse events throughout the trial. Results will be submitted for publication after enrolment and follow-up are complete.
    Keywords covid19
    Language English
    Publishing date 2020-06-26
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.06.24.20139303
    Database COVID19

    Full text online

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  2. Article ; Online: Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial.

    Tomazini, Bruno M / Maia, Israel S / Cavalcanti, Alexandre B / Berwanger, Otavio / Rosa, Regis G / Veiga, Viviane C / Avezum, Alvaro / Lopes, Renato D / Bueno, Flavia R / Silva, Maria Vitoria A O / Baldassare, Franca P / Costa, Eduardo L V / Moura, Ricardo A B / Honorato, Michele O / Costa, Andre N / Damiani, Lucas P / Lisboa, Thiago / Kawano-Dourado, Letícia / Zampieri, Fernando G /
    Olivato, Guilherme B / Righy, Cassia / Amendola, Cristina P / Roepke, Roberta M L / Freitas, Daniela H M / Forte, Daniel N / Freitas, Flávio G R / Fernandes, Caio C F / Melro, Livia M G / Junior, Gedealvares F S / Morais, Douglas Costa / Zung, Stevin / Machado, Flávia R / Azevedo, Luciano C P

    JAMA

    2020  Volume 324, Issue 13, Page(s) 1307–1316

    Abstract: Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients.: Objective: ... ...

    Abstract Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients.
    Objective: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS.
    Design, setting, and participants: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.
    Interventions: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148).
    Main outcomes and measures: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.
    Results: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.
    Conclusions and relevance: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.
    Trial registration: ClinicalTrials.gov Identifier: NCT04327401.
    MeSH term(s) Administration, Intravenous ; Aged ; Anti-Inflammatory Agents/adverse effects ; Anti-Inflammatory Agents/therapeutic use ; Betacoronavirus ; Brazil ; COVID-19 ; Catheter-Related Infections/epidemiology ; Coronavirus Infections/complications ; Coronavirus Infections/drug therapy ; Coronavirus Infections/mortality ; Coronavirus Infections/therapy ; Dexamethasone/adverse effects ; Dexamethasone/therapeutic use ; Early Termination of Clinical Trials ; Female ; Humans ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/complications ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/mortality ; Pneumonia, Viral/therapy ; Respiration, Artificial/statistics & numerical data ; Respiratory Distress Syndrome/drug therapy ; Respiratory Distress Syndrome/etiology ; SARS-CoV-2 ; COVID-19 Drug Treatment
    Chemical Substances Anti-Inflammatory Agents ; Dexamethasone (7S5I7G3JQL)
    Keywords covid19
    Language English
    Publishing date 2020-08-24
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.17021
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.88: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article: Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial

    Tomazini, Bruno M / Maia, Israel S / Cavalcanti, Alexandre B / Berwanger, Otavio / Rosa, Regis G / Veiga, Viviane C / Avezum, Alvaro / Lopes, Renato D / Bueno, Flavia R / Silva, Maria Vitoria A O / Baldassare, Franca P / Costa, Eduardo L V / Moura, Ricardo A B / Honorato, Michele O / Costa, Andre N / Damiani, Lucas P / Lisboa, Thiago / Kawano-Dourado, Letícia / Zampieri, Fernando G /
    Olivato, Guilherme B / Righy, Cassia / Amendola, Cristina P / Roepke, Roberta M L / Freitas, Daniela H M / Forte, Daniel N / Freitas, Flávio G R / Fernandes, Caio C F / Melro, Livia M G / Junior, Gedealvares F S / Morais, Douglas Costa / Zung, Stevin / Machado, Flávia R / Azevedo, Luciano C P

    JAMA

    Abstract: Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. Objective: To ... ...

    Abstract Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. Objective: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. Design, Setting, and Participants: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. Interventions: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148). Main Outcomes and Measures: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. Results: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. Conclusions and Relevance: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04327401.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #739602
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  4. Article ; Online: Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19 ; The CoDEX Randomized Clinical Trial

    Tomazini, Bruno M. / Maia, Israel S. / Cavalcanti, Alexandre B. / Berwanger, Otavio / Rosa, Regis G. / Veiga, Viviane C. / Avezum, Alvaro / Lopes, Renato D. / Bueno, Flavia R. / Silva, Maria Vitoria A. O. / Baldassare, Franca P. / Costa, Eduardo L. V. / Moura, Ricardo A. B. / Honorato, Michele O. / Costa, Andre N. / Damiani, Lucas P. / Lisboa, Thiago / Kawano-Dourado, Letícia / Zampieri, Fernando G. /
    Olivato, Guilherme B. / Righy, Cassia / Amendola, Cristina P. / Roepke, Roberta M. L. / Freitas, Daniela H. M. / Forte, Daniel N. / Freitas, Flávio G. R. / Fernandes, Caio C. F. / Melro, Livia M. G. / Junior, Gedealvares F. S. / Morais, Douglas Costa / Zung, Stevin / Machado, Flávia R. / Azevedo, Luciano C. P.

    JAMA

    2020  Volume 324, Issue 13, Page(s) 1307

    Keywords General Medicine ; covid19
    Language English
    Publisher American Medical Association (AMA)
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.17021
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.88: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top