6 results on '"Leistner, Jens W"'
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2. Heterogeneity of treatment effect of higher dose dexamethasone by geographic region (Europe vs. India) in patients with COVID-19 and severe hypoxemia – a post hoc evaluation of the COVID STEROID 2 trial
- Author
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Tirupakuzhi Vijayaraghavan, Bharath Kumar, primary, Granholm, Anders, additional, Myatra, Sheila N., additional, Jha, Vivekanand, additional, Hammond, Naomi, additional, Micallef, Sharon, additional, Munch, Marie Warrer, additional, Kjær, Maj-Brit N., additional, Møller, Morten Hylander, additional, Lange, Theis, additional, Perner, Anders, additional, Venkatesh, Balasubramanian, additional, Munch, Marie W., additional, Tirupakuzhi Vijayaraghavan, Bharath Kumar, additional, Saseedharan, Sanjith, additional, Benfield, Thomas, additional, Wahlin, Rebecka R., additional, Rasmussen, Bodil S., additional, Andreasen, Anne Sofie, additional, Poulsen, Lone M., additional, Cioccari, Luca, additional, Khan, Mohd S., additional, Kapadia, Farhad, additional, Divatia, Jigeeshu V., additional, Brøchner, Anne C., additional, Bestle, Morten H., additional, Helleberg, Marie, additional, Michelsen, Jens, additional, Padmanaban, Ajay, additional, Bose, Neeta, additional, Møller, Anders, additional, Borawake, Kapil, additional, Kristiansen, Klaus T., additional, Shukla, Urvi, additional, Chew, Michelle S., additional, Dixit, Subhal, additional, Ulrik, Charlotte S., additional, Amin, Pravin R., additional, Chawla, Rajesh, additional, Wamberg, Christian A., additional, Shah, Mehul S., additional, Darfelt, Iben S., additional, Jørgensen, Vibeke L., additional, Smitt, Margit, additional, Møller, Morten H., additional, Meyhoff, Tine S., additional, Vesterlund, Gitte K., additional, Hammond, Naomi E., additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Anubhuti, additional, Cronhjort, Maria, additional, Jakob, Stephan M., additional, Gluud, Christian, additional, Kadam, Vaijayanti, additional, Marcussen, Klaus V., additional, Hollenberg, Jacob, additional, Hedman, Anders, additional, Nielsen, Henrik, additional, Schjørring, Olav L., additional, Jensen, Marie Q., additional, Leistner, Jens W., additional, Jonassen, Trine B., additional, Kristensen, Camilla M., additional, Clapp, Esben C., additional, Hjortsø, Carl J.S., additional, Jensen, Thomas S., additional, Halstad, Liv S., additional, Bak, Emilie R.B., additional, Zaabalawi, Reem, additional, Metcalf-Clausen, Matias, additional, Abdi, Suhayb, additional, Hatley, Emma V., additional, Aksnes, Tobias S., additional, Gleipner-Andersen, Emil, additional, Alarcón, A.Felix, additional, Yamin, Gabriel, additional, Heymowski, Adam, additional, Berggren, Anton, additional, la Cour, Kirstine, additional, Weihe, Sarah, additional, Pind, Alison H., additional, and Engstrøm, Janus, additional
- Published
- 2023
- Full Text
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3. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia:The COVID STEROID 2 Randomized Trial
- Author
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Munch, Marie W, Myatra, Sheila N, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R, Rasmussen, Bodil S, Andreasen, Anne Sofie, Poulsen, Lone M, Cioccari, Luca, Khan, Mohd S, Kapadia, Farhad, Divatia, Jigeeshu V, Br��chner, Anne C, Bestle, Morten H, Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, M��ller, Anders, Borawake, Kapil, Kristiansen, Klaus T, Shukla, Urvi, Chew, Michelle S, Dixit, Subhal, Ulrik, Charlotte S, Amin, Pravin R, Chawla, Rajesh, Wamberg, Christian A, Shah, Mehul S, Darfelt, Iben S, J��rgensen, Vibeke L, Smitt, Margit, Granholm, Anders, Kj��r, Maj-Brit N, M��ller, Morten H, Meyhoff, Tine S, Vesterlund, Gitte K, Hammond, Naomi E, Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M, Gluud, Christian, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V, Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schj��rring, Olav L, Jensen, Marie Q, Leistner, Jens W, Jonassen, Trine B, Kristensen, Camilla M, Clapp, Esben C, Hjorts��, Carl J S, Jensen, Thomas S, Halstad, Liv S, Bak, Emilie R B, Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V, Aksnes, Tobias S, Gleipner-Andersen, Emil, Alarc��n, Arif F, Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H, Engstr��m, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, and Perner, Anders
- Subjects
Dexamethasone/administration & dosage ,Male ,Mycoses/etiology ,medicine.medical_treatment ,Dexamethasone ,Hypoxemia ,law.invention ,Randomized controlled trial ,law ,medicine ,Shock, Septic/etiology ,Humans ,Single-Blind Method ,Hypoxia ,610 Medicine & health ,Glucocorticoids ,Aged ,Mechanical ventilation ,Dose-Response Relationship, Drug ,Septic shock ,business.industry ,Hypoxia/etiology ,COVID-19 ,Glucocorticoids/administration & dosage ,General Medicine ,Middle Aged ,medicine.disease ,Shock, Septic ,Respiration, Artificial ,COVID-19 Drug Treatment ,Life Support Care ,Dose–response relationship ,Mycoses ,Relative risk ,Anesthesia ,Life support ,COVID-19/complications ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Importance A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n���=���503) or 6 mg/d of intravenous dexamethasone (n���=���497) for up to 10 days. Main Outcomes and Measures The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ���1 serious adverse reactions at 28 days). Results Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P���=���.07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.
- Published
- 2021
4. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia The COVID STEROID 2 Randomized Trial
- Author
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Munch, Marie W., Myatra, Sheila N., Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R., Rasmussen, Bodil S., Andreasen, Anne Sofie, Poulsen, Lone M., Cioccari, Luca, Khan, Mohd S., Kapadia, Farhad, Divatia, Jigeeshu V., Brochner, Anne C., Bestle, Morten H., Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, Møller, Anders, Borawake, Kapil, Kristiansen, Klaus T., Shukla, Urvi, Chew, Michelle S., Dixit, Subhal, Ulrik, Charlotte S., Amin, Pravin R., Chawla, Rajesh, Wamberg, Christian A., Shah, Mehul S., Darfelt, Iben S., Jorgensen, Vibeke L., Smitt, Margit, Granholm, Anders, Kjær, Maj-Brit N., Møller, Morten H., Meyhoff, Tine S., Vesterlund, Gitte K., Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M., Gluud, Christian, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V., Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schjorring, Olav L., Jensen, Marie Q., Leistner, Jens W., Jonassen, Trine B., Kristensen, Camilla M., Clapp, Esben C., Hjortso, Carl J. S., Jensen, Thomas S., Halstad, Liv S., Bak, Emilie R. B., Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V., Aksnes, Tobias S., Gleipner-Andersen, Emil, Alarcon, Arif F., Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H., Engstrom, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, Perner, Anders, Munch, Marie W., Myatra, Sheila N., Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R., Rasmussen, Bodil S., Andreasen, Anne Sofie, Poulsen, Lone M., Cioccari, Luca, Khan, Mohd S., Kapadia, Farhad, Divatia, Jigeeshu V., Brochner, Anne C., Bestle, Morten H., Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, Møller, Anders, Borawake, Kapil, Kristiansen, Klaus T., Shukla, Urvi, Chew, Michelle S., Dixit, Subhal, Ulrik, Charlotte S., Amin, Pravin R., Chawla, Rajesh, Wamberg, Christian A., Shah, Mehul S., Darfelt, Iben S., Jorgensen, Vibeke L., Smitt, Margit, Granholm, Anders, Kjær, Maj-Brit N., Møller, Morten H., Meyhoff, Tine S., Vesterlund, Gitte K., Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M., Gluud, Christian, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V., Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schjorring, Olav L., Jensen, Marie Q., Leistner, Jens W., Jonassen, Trine B., Kristensen, Camilla M., Clapp, Esben C., Hjortso, Carl J. S., Jensen, Thomas S., Halstad, Liv S., Bak, Emilie R. B., Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V., Aksnes, Tobias S., Gleipner-Andersen, Emil, Alarcon, Arif F., Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H., Engstrom, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, and Perner, Anders
- Abstract
Importance A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86
- Published
- 2021
5. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial (vol 326, pg 1807, 2021)
- Author
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Munch, Marie W., Myatra, Sheila N., Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R., Rasmussen, Bodil S., Andreasen, Anne Sofie, Poulsen, Lone M., Cioccari, Luca, Khan, Mohd S., Kapadia, Farhad, Divatia, Jigeeshu V., Brochner, Anne C., Bestle, Morten H., Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, Moller, Anders, Borawake, Kapil, Kristiansen, Klaus T., Shukla, Urvi, Chew, Michelle S., Dixit, Subhal, Ulrik, Charlotte S., Amin, Pravin R., Chawla, Rajesh, Wamberg, Christian A., Shah, Mehul S., Darfelt, Iben S., Jorgensen, Vibeke L., Smitt, Margit, Granholm, Anders, Kjaer, Maj-Brit N., Moller, Morten H., Meyhoff, Tine S., Vesterlund, Gitte K., Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M., Christian Gluud, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V., Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schjorring, Olav L., Jensen, Marie Q., Leistner, Jens W., Jonassen, Trine B., Kristensen, Camilla M., Clapp, Esben C., Hjortso, Carl J. S., Jensen, Thomas S., Halstad, Liv S., Bak, Emilie R. B., Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V., Aksnes, Tobias S., Gleipner-Andersen, Emil, Alarcon, Arif F., Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H., Engstrom, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, and Perner, Anders
6. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial.
- Author
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Munch MW, Myatra SN, Vijayaraghavan BKT, Saseedharan S, Benfield T, Wahlin RR, Rasmussen BS, Andreasen AS, Poulsen LM, Cioccari L, Khan MS, Kapadia F, Divatia JV, Brøchner AC, Bestle MH, Helleberg M, Michelsen J, Padmanaban A, Bose N, Møller A, Borawake K, Kristiansen KT, Shukla U, Chew MS, Dixit S, Ulrik CS, Amin PR, Chawla R, Wamberg CA, Shah MS, Darfelt IS, Jørgensen VL, Smitt M, Granholm A, Kjær MN, Møller MH, Meyhoff TS, Vesterlund GK, Hammond NE, Micallef S, Bassi A, John O, Jha A, Cronhjort M, Jakob SM, Gluud C, Lange T, Kadam V, Marcussen KV, Hollenberg J, Hedman A, Nielsen H, Schjørring OL, Jensen MQ, Leistner JW, Jonassen TB, Kristensen CM, Clapp EC, Hjortsø CJS, Jensen TS, Halstad LS, Bak ERB, Zaabalawi R, Metcalf-Clausen M, Abdi S, Hatley EV, Aksnes TS, Gleipner-Andersen E, Alarcón AF, Yamin G, Heymowski A, Berggren A, La Cour K, Weihe S, Pind AH, Engstrøm J, Jha V, Venkatesh B, and Perner A
- Subjects
- Aged, COVID-19 complications, COVID-19 mortality, Dexamethasone adverse effects, Dose-Response Relationship, Drug, Female, Glucocorticoids adverse effects, Humans, Hypoxia etiology, Hypoxia therapy, Male, Middle Aged, Mycoses etiology, Respiration, Artificial, Shock, Septic etiology, Single-Blind Method, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Life Support Care, COVID-19 Drug Treatment
- Abstract
Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease., Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia., Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021., Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days., Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days)., Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29])., Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference., Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.
- Published
- 2021
- Full Text
- View/download PDF
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