A double-blind placebo-controlled study to evaluate the safety and efficacy of L-2-oxothiazolidine-4-carboxylic acid in the treatment of patients with acute respiratory distress syndrome

Critical Care Medicine
P E MorrisG R Bernard

Abstract

Acute respiratory distress syndrome is an abrupt inflammatory illness that involves damage from reactive oxygen species. We examined the efficacy and safety of oxothiazolidine-4-carboxylic acid (OTZ), a free radical scavenger, in treating acute respiratory distress syndrome. Double-blind, placebo-controlled trial. Multicentered study. Patients with a PaO2/FiO2 < or = 200 and bilateral infiltrates on chest radiograph, and requiring mechanical ventilation. We randomized 215 patients to receive OTZ, 210 mg/kg per day every 8 hrs for 14 days or placebo. Ventilator-free days (the number of days alive and free from ventilator requirement) during the first 30 days of study were 8.3 vs. 13.5 days for the OTZ and placebo groups, respectively (p < .001). Mortality was 30/101 (29.7%) in the OTZ group and 18/114 (15.8%) in the placebo group during the 30-day study period (p = .014). This study was terminated prematurely for safety reasons after 215 of the planned 352 patients were enrolled. OTZ does not improve survival or reduce ventilator time in patients with acute respiratory distress syndrome and may worsen outcome, although mortality in the OTZ group was similar or lower than most similar trials. Alternatively, our results may be bes...Continue Reading

References

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Citations

Jan 16, 2010·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Elizabeth R Johnson, Michael A Matthay
May 18, 2013·The Journal of Antimicrobial Chemotherapy·Keisuke SaitoKazuhiro Tateda
Apr 24, 2008·Critical Care Medicine·James M O'Brien, Scott K Aberegg
Jan 20, 2009·American Journal of Respiratory and Critical Care Medicine·Jaroslaw W ZmijewskiEdward Abraham
Jul 3, 2010·American Journal of Respiratory Cell and Molecular Biology·Sandra HodgePaul N Reynolds
Jun 29, 2011·Translational Research : the Journal of Laboratory and Clinical Medicine·Phillip Factor
Dec 2, 2008·Microvascular Research·Adel Boueiz, Paul M Hassoun
Aug 29, 2012·Pulmonary Pharmacology & Therapeutics·Amsel M SioreKenneth L Brigham
Jan 26, 2017·Microcirculation : the Official Journal of the Microcirculatory Society, Inc·Jamie E MeeganSarah Y Yuan
Jul 25, 2019·The Cochrane Database of Systematic Reviews·Sharon R LewisAndrew F Smith
Oct 24, 2018·NeuroRehabilitation·Sangeeta Driver, Ryan Stork
May 2, 2009·Journal of Applied Physiology·Leonardo F FerreiraMichael B Reid
Jun 9, 2020·Current Problems in Surgery·Nathan T MoweryAdam C Nelson

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