![]() ![]() Trial Registration Identifier: NCT03509350 However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference. ![]() Thirty-day mortality was 22% in the intervention group and 24% in the placebo group.Ĭonclusions and Relevance Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of −1 day (95% CI, −4 to 2 days P = .85). Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Results Among 501 participants randomized (median age, 62 years 46% female 30% Black median Acute Physiology and Chronic Health Evaluation II score, 27 median Sequential Organ Failure Assessment score, 9 ), all completed the trial. The key secondary outcome was 30-day mortality. Main Outcomes and Measures The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone. Interventions Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n = 252) or matching placebo (n = 249) for 96 hours or until discharge from the intensive care unit or death. All study-related follow-up was completed by January 2020. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. Objective To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis.ĭesign, Setting, and Participants Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis. Importance Sepsis is a common syndrome with substantial morbidity and mortality. Wesley Ely, MD, PhD 5,9,10 Lindsay M. Eyzaguirre, MS 11 Alpha A. Fowler, MD 8 David F. Gaieski, MD 12 Michelle N. Gong, MD 13 Alex Hall, DHSc, MS 14 Jeremiah S. Hinson, MD, PhD 3 Michael H. Hooper, MD 15 Gabor D. Kelen, MD 3 Akram Khan, MD 16 Mark A. Levine, MD 17 Roger J. Lewis, MD, PhD 18,19,20,21 Chris J. Lindsell, PhD 22 Jessica S. Marlin, CCRP 23 Anna McGlothlin, PhD 19 Brooks L. Moore, MD 14 Katherine L. Nugent, MD 14 Samuel Nwosu, MS 22 Carmen C. Polito, MD, MSc 1,2 Todd W. Rice, MD, MSc 5 Erin P. Ricketts, MSPH 3 Caroline C. Rudolph, MBA 14 Fred Sanfilippo, MD, PhD 24 Kert Viele, PhD 19,25 Greg S. Martin, MD, MSc 1,2 David W. Wright, MD 14 for the VICTAS Investigators Jonathan E. Sevransky, MD, MHS 1,2 Richard E. Rothman, MD, PhD 3 David N. Hager, MD, PhD 4 et al Gordon R. Bernard, MD 5 Samuel M. Brown, MD 6 Timothy G. Buchman, PhD, MD 2,7 Laurence W. Busse, MD, MBA 1,2 Craig M. Coopersmith, MD 2,7 Christine DeWilde, PhD 8 E. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |