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

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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

Munch, Marie W. (författare): Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Myatra, Sheila N. (författare): Copenhagen Univ Hosp, Denmark; Tata Mem Hosp, India

Vijayaraghavan, Bharath Kumar Tirupakuzhi (författare): Apollo Hosp, India

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Saseedharan, Sanjith (författare): SL Raheja Hosp, India,Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark,Rajendra Inst Med Sci, India,Sir HN Reliance Fdn Hosp & Res Ctr, India,Herning Hosp, Denmark

Benfield, Thomas (författare): Copenhagen Univ Hosp Amager & Hvidovre, Denmark

Wahlin, Rebecka R. (författare): Karolinska Institutet,Karolinska Inst, Sweden

Rasmussen, Bodil S. (författare): Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark

Andreasen, Anne Sofie (författare): Department of Anaesthesia and Intensive Care, Copenhagen University Hospital, Herlev-Gentofte Hospital, Herlev, Denmark

Poulsen, Lone M. (författare): Zealand Univ Hosp, Denmark

Cioccari, Luca (författare): Univ Bern, Switzerland

Khan, Mohd S. (författare): Rajendra Inst Med Sci, India

Kapadia, Farhad (författare): Hinduja Hosp, India

Divatia, Jigeeshu V. (författare): Tata Mem Hosp, India

Brochner, Anne C. (författare): Kolding Cty Hosp, Denmark

Bestle, Morten H. (författare): Copenhagen Univ Hosp, Denmark

Helleberg, Marie (författare): Copenhagen Univ Hosp, Denmark

Michelsen, Jens (författare): Odense Univ Hosp, Denmark

Padmanaban, Ajay (författare): Apollo Hospitals, Chennai, India

Bose, Neeta (författare): Gotri Gen Hosp, India

Moller, Anders (författare): Slagelse Hosp, Denmark

Borawake, Kapil (författare): Vishwaraj Hosp, India

Kristiansen, Klaus T. (författare): Copenhagen Univ Hosp, Denmark

Shukla, Urvi (författare): Symbiosis Univ Hosp, India

Chew, Michelle (författare): Linköpings universitet,Avdelningen för klinisk kemi och farmakologi,Medicinska fakulteten,Region Östergötland, ANOPIVA US

Dixit, Subhal (författare): Sanjeevan Hosp, India

Ulrik, Charlotte S. (författare): Copenhagen Univ Hosp, Denmark

Amin, Pravin R. (författare): Bombay Hosp Inst Med Sci, India

Chawla, Rajesh (författare): Indraprastha Apollo Hosp, India

Wamberg, Christian A. (författare): Frederiksberg Univ Hosp, Denmark

Shah, Mehul S. (författare): Sir HN Reliance Fdn Hosp & Res Ctr, India

Darfelt, Iben S. (författare): Herning Hosp, Denmark

Jorgensen, Vibeke L. (författare): Copenhagen Univ Hosp, Denmark

Smitt, Margit (författare): Copenhagen Univ Hosp, Denmark

Granholm, Anders (författare): Copenhagen Univ Hosp, Denmark

Kjaer, Maj-Brit N. (författare): Copenhagen Univ Hosp, Denmark

Moller, Morten H. (författare): Copenhagen Univ Hosp, Denmark

Meyhoff, Tine S. (författare): Copenhagen Univ Hosp, Denmark

Vesterlund, Gitte K. (författare): Copenhagen Univ Hosp, Denmark

Hammond, Naomi E. (författare): Copenhagen Univ Hosp, Denmark; Univ New South Wales, Australia; Royal North Shore Hosp, Australia

Micallef, Sharon (författare): Univ New South Wales, Australia

Bassi, Abhinav (författare): George Inst Global Hlth, India

John, Oommen (författare): George Inst Global Hlth, India; Manipal Acad Med Sci, India

Jha, Anubhuti (författare): George Inst Global Hlth, India

Cronhjort, Maria (författare): Karolinska Institutet,Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden

Jakob, Stephan M. (författare): Univ Bern, Switzerland

Gluud, Christian (författare): Copenhagen Univ Hosp, Denmark; Univ Southern Denmark, Denmark

Lange, Theis (författare): Univ Copenhagen, Denmark

Kadam, Vaijayanti (författare): SL Raheja Hospital, Mumbai, India

Marcussen, Klaus V. (författare): Slagelse Hosp, Denmark

Hollenberg, Jacob (författare): Karolinska Institutet,Karolinska Inst, Sweden

Hedman, Anders (författare): Karolinska Institutet,Karolinska Inst, Sweden

Nielsen, Henrik (författare): Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark

Schjorring, Olav L. (författare): Aalborg Univ Hosp, Denmark; Copenhagen Univ Hosp, Denmark

Jensen, Marie Q. (författare): Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Leistner, Jens W. (författare): Copenhagen Univ Hosp, Denmark

Jonassen, Trine B. (författare): Copenhagen Univ Hosp, Denmark

Kristensen, Camilla M. (författare): Copenhagen Univ Hosp, Denmark

Clapp, Esben C. (författare): Copenhagen Univ Hosp, Denmark

Hjortso, Carl J. S. (författare): Copenhagen Univ Hosp, Denmark

Jensen, Thomas S. (författare): Copenhagen Univ Hosp, Denmark

Halstad, Liv S. (författare): Copenhagen Univ Hosp, Denmark

Bak, Emilie R. B. (författare): Copenhagen Univ Hosp, Denmark

Zaabalawi, Reem (författare): Copenhagen Univ Hosp, Denmark

Metcalf-Clausen, Matias (författare): Copenhagen Univ Hosp, Denmark

Abdi, Suhayb (författare): Copenhagen Univ Hosp, Denmark

Hatley, Emma V. (författare): Copenhagen Univ Hosp, Denmark

Aksnes, Tobias S. (författare): Copenhagen Univ Hosp, Denmark

Gleipner-Andersen, Emil (författare): Copenhagen Univ Hosp, Denmark

Alarcon, Arif F. (författare): Copenhagen Univ Hosp, Denmark; Karolinska Inst, Sweden

Yamin, Gabriel (författare): Karolinska Inst, Sweden

Heymowski, Adam (författare): Karolinska Inst, Sweden

Berggren, Anton (författare): Karolinska Inst, Sweden

La Cour, Kirstine (författare): Department of Anaesthesia and Intensive Care, Zealand University Hospital, Koege, Denmark

Weihe, Sarah (författare): Zealand Univ Hosp, Denmark

Pind, Alison H. (författare): Zealand Univ Hosp, Denmark

Engstrom, Janus (författare): Copenhagen Univ Hosp, Denmark

Jha, Vivekanand (författare): Univ New South Wales, Australia; Manipal Acad Med Sci, India; Imperial Coll, England

Venkatesh, Balasubramanian (författare): Univ New South Wales, Australia; George Inst Global Hlth, India; Wesley Hosp, Australia

Perner, Anders (författare): Copenhagen Univ Hosp, Denmark; Apollo Hosp, India; Univ New South Wales, Australia

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(creator_code:org_t)

AMER MEDICAL ASSOC, 2021
2021
Engelska.
Ingår i: Journal of the American Medical Association (JAMA). - : AMER MEDICAL ASSOC. - 0098-7484 .- 1538-3598. ; 326:18, s. 1807-1817

Relaterad länk:: https://jamanetwork....; visa fler...; https://urn.kb.se/re...; https://doi.org/10.1...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

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Question What is the effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support at 28 days in patients with COVID-19 and severe hypoxemia? Findings In this randomized trial that included 1000 patients with COVID-19 and severe hypoxemia, treatment with 12 mg/d of dexamethasone resulted in 22.0 days alive without life support at 28 days compared with 20.5 days in those receiving 6 mg/d of dexamethasone. This difference was not statistically significant. Meaning Compared with 6 mg of dexamethasone, 12 mg of dexamethasone did not statistically significantly reduce the number of days alive without life support at 28 days. This multicenter randomized clinical trial compares the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. 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.

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Av författaren/redakt...: Munch, Marie W.; Myatra, Sheila N ...; Vijayaraghavan, ...; Saseedharan, San ...; Benfield, Thomas; Wahlin, Rebecka ...; visa fler...; Rasmussen, Bodil ...; Andreasen, Anne ...; Poulsen, Lone M.; Cioccari, Luca; Khan, Mohd S.; Kapadia, Farhad; Divatia, Jigeesh ...; Brochner, Anne C ...; Bestle, Morten H ...; Helleberg, Marie; Michelsen, Jens; Padmanaban, Ajay; Bose, Neeta; Moller, Anders; Borawake, Kapil; Kristiansen, Kla ...; Shukla, Urvi; Chew, Michelle; Dixit, Subhal; Ulrik, Charlotte ...; Amin, Pravin R.; Chawla, Rajesh; Wamberg, Christi ...; Shah, Mehul S.; Darfelt, Iben S.; Jorgensen, Vibek ...; Smitt, Margit; Granholm, Anders; Kjaer, Maj-Brit ...; Moller, Morten H ...; Meyhoff, Tine S.; Vesterlund, Gitt ...; Hammond, Naomi E ...; Micallef, Sharon; Bassi, Abhinav; John, Oommen; Jha, Anubhuti; Cronhjort, Maria; Jakob, Stephan M ...; Gluud, Christian; Lange, Theis; Kadam, Vaijayant ...; Marcussen, Klaus ...; Hollenberg, Jaco ...; Hedman, Anders; Nielsen, Henrik; Schjorring, Olav ...; Jensen, Marie Q.; Leistner, Jens W ...; Jonassen, Trine ...; Kristensen, Cami ...; Clapp, Esben C.; Hjortso, Carl J. ...; Jensen, Thomas S ...; Halstad, Liv S.; Bak, Emilie R. B ...; Zaabalawi, Reem; Metcalf-Clausen, ...; Abdi, Suhayb; Hatley, Emma V.; Aksnes, Tobias S ...; Gleipner-Anderse ...; Alarcon, Arif F.; Yamin, Gabriel; Heymowski, Adam; Berggren, Anton; La Cour, Kirstin ...; Weihe, Sarah; Pind, Alison H.; Engstrom, Janus; Jha, Vivekanand; Venkatesh, Balas ...; Perner, Anders; visa färre...

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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

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