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      Prolonged low-dose methylprednisolone treatment is highly effective in reducing duration of mechanical ventilation and mortality in patients with ARDS

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          Abstract

          An updated meta-analysis incorporating nine randomized trials ( n = 816) investigating low-to-moderate dose prolonged glucocorticoid treatment in acute respiratory distress syndrome (ARDS) show moderate-to-high quality evidence that glucocorticoid therapy is safe and reduces (i) time to endotracheal extubation, (ii) duration of hospitalization, and (iii) mortality (number to treat to save one life = 7), and increases the number of days free from (i) mechanical ventilation, (ii) intensive care unit stay, and (iii) hospitalization. Recent guideline suggests administering methylprednisolone in patients with early moderate-to-severe (1 mg/kg/day) and late persistent (2 mg/kg/day) ARDS (conditional recommendation based on moderate quality of evidence).

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          Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study.

          Marco Confalonieri, Rosario Urbino, Alfredo Potena … (2005)
          We hypothesize that hydrocortisone infusion in severe community-acquired pneumonia attenuates systemic inflammation and leads to earlier resolution of pneumonia and a reduction in sepsis-related complications. In a multicenter trial, patients admitted to the Intensive Care Unit (ICU) with severe community-acquired pneumonia received protocol-guided antibiotic treatment and were randomly assigned to hydrocortisone infusion or placebo. Hydrocortisone was given as an intravenous 200-mg bolus followed by infusion at a rate of 10 mg/hour for 7 days. Primary end-points of the study were improvement in Pa(O(2)):FI(O(2)) (Pa(O(2)):FI(O(2)) > 300 or >/= 100 increase from study entry) and multiple organ dysfunction syndrome (MODS) score by Study Day 8 and reduction in delayed septic shock. Forty-six patients entered the study. At study entry, the hydrocortisone group had lower Pa(O(2)):FI(O(2)), and higher chest radiograph score and C-reactive protein level. By Study Day 8, treated patients had, compared with control subjects, a significant improvement in Pa(O(2)):FI(O(2)) (p = 0.002) and chest radiograph score (p < 0.0001), and a significant reduction in C-reactive protein levels (p = 0.01), MODS score (p = 0.003), and delayed septic shock (p = 0.001). Hydrocortisone treatment was associated with a significant reduction in length of hospital stay (p = 0.03) and mortality (p = 0.009).
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            High-dose corticosteroids in patients with the adult respiratory distress syndrome.

            G R Bernard, J Luce, C. L. Sprung … (1987)
            Corticosteroids are widely used as therapy for the adult respiratory distress syndrome (ARDS) without proof of efficacy. We conducted a prospective, randomized, double-blind, placebo-controlled trial of methylprednisolone therapy in 99 patients with refractory hypoxemia, diffuse bilateral infiltrates on chest radiography and absence of congestive heart failure documented by pulmonary-artery catheterization. The causes of ARDS included sepsis (27 percent), aspiration pneumonia (18 percent), pancreatitis (4 percent), shock (2 percent), fat emboli (1 percent), and miscellaneous causes or more than one cause (42 percent). Fifty patients received methylprednisolone (30 mg per kilogram of body weight every six hours for 24 hours), and 49 received placebo according to the same schedule. Serial measurements were made of pulmonary shunting, the ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen, the chest radiograph severity score, total thoracic compliance, and pulmonary-artery pressure. We observed no statistical differences between groups in these characteristics upon entry or during the five days after entry. Forty-five days after entry there were no differences between the methylprednisolone and placebo groups in mortality (respectively, 30 of 50 [60 percent; 95 percent confidence interval, 46 to 74] and 31 of 49 [63 percent; 95 percent confidence interval, 49 to 77]; P = 0.74) or in the reversal of ARDS (18 of 50 [36 percent] vs. 19 of 49 [39 percent]; P = 0.77). However, the relatively wide confidence intervals in the mortality data make it impossible to exclude a small effect of treatment. Infectious complications were similar in the methylprednisolone group (8 of 50 [16 percent]) and the placebo group (5 of 49 [10 percent]; P = 0.60). Our data suggest that in patients with established ARDS due to sepsis, aspiration, or a mixed cause, high-dose methylprednisolone does not affect outcome.
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              Effect of prolonged methylprednisolone therapy in unresolving acute respiratory distress syndrome: a randomized controlled trial.

              E. Tolley, Arthur S. Headley, B R Umberger … (1998)
              No pharmacological therapeutic protocol has been found effective in modifying the clinical course of acute respiratory distress syndrome (ARDS) and mortality remains greater than 50%. To determine the effects of prolonged methylprednisolone therapy on lung function and mortality in patients with unresolving ARDS. Randomized, double-blind, placebo-controlled trial. Medical intensive care units of 4 medical centers. Twenty-four patients with severe ARDS who had failed to improve lung injury score (LIS) by the seventh day of respiratory failure. Sixteen patients received methylprednisolone and 8 received placebo. Methylprednisolone dose was initially 2 mg/kg per day and the duration of treatment was 32 days. Four patients whose LIS failed to improve by at least 1 point after 10 days of treatment were blindly crossed over to the alternative treatment. Primary outcome measures were improvement in lung function and mortality. Secondary outcome measures were improvement in multiple organ dysfunction syndrome (MODS) and development of nosocomial infections. Physiological characteristics at the onset of ARDS were similar in both groups. At study entry (day 9 [SD, 3] of ARDS), the 2 groups had similar LIS, ratios of PaO2 to fraction of inspired oxygen (FIO2), and MODS scores. Changes observed by study day 10 for methylprednisolone vs placebo were as follows: reduced LIS (mean [SEM], 1.7 [0.1] vs 3.0 [0.2]; P<.001); improved ratio of PaO2 to FIO2 (mean [SEM], 262 [19] vs 148 [35]; P<.001); decreased MODS score (mean [SEM], 0.7 [0.2] vs 1.8 [0.3]; P<.001); and successful extubation (7 vs 0; P=.05). For the treatment group vs the placebo group, mortality associated with the intensive care unit was 0 (0%) of 16 vs 5 (62%) of 8 (P=.002) and hospital-associated mortality was 2 (12%) of 16 vs 5 (62%) of 8 (P=.03). The rate of infections per day of treatment was similar in both groups, and pneumonia was frequently detected in the absence of fever. In this study, prolonged administration of methylprednisolone in patients with unresolving ARDS was associated with improvement in lung injury and MODS scores and reduced mortality.
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                Author and article information

                Contributors
                Gianfranco Umberto Meduri: 901-577-7520 , gmeduri@uthsc.edu
                Reed A. C. Siemieniuk: reed.siemieniuk@medportal.ca
                Rachel A. Ness: Rachel.Ness2@va.gov
                Samuel J. Seyler: samseyler@gmail.com
                Journal
                Journal ID (nlm-ta): J Intensive Care
                Journal ID (iso-abbrev): J Intensive Care
                Title: Journal of Intensive Care
                Publisher: BioMed Central (London )
                ISSN (Electronic): 2052-0492
                Publication date (Electronic): 24 August 2018
                Publication date PMC-release: 24 August 2018
                Publication date Collection: 2018
                Volume: 6
                Electronic Location Identifier: 53
                Affiliations
                [1 ]ISNI 0000 0004 0420 4721, GRID grid.413847.d, Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, , Memphis Veterans Affairs Medical Center (111), ; 1030 Jefferson Avenue, Suite room #CW444, Memphis, TN 38104 USA
                [2 ]ISNI 0000 0004 1936 8227, GRID grid.25073.33, Department of Health Research Methods, Evidence, and Impact, , McMaster University, ; Hamilton, Ontario Canada
                [3 ]ISNI 0000 0001 2157 2938, GRID grid.17063.33, Department of Medicine, , University of Toronto, ; Toronto, Ontario Canada
                [4 ]ISNI 0000 0004 0420 4721, GRID grid.413847.d, Department of Pharmacy, , Memphis Veterans Affairs Medical Center, ; Memphis, TN USA
                [5 ]ISNI 0000 0004 0386 9246, GRID grid.267301.1, Department of Medicine and Pediatrics, , University of Tennessee Health Science Center, ; Memphis, TN USA
                [6 ]ISNI 0000 0001 0667 4960, GRID grid.272458.e, Department of Anesthesiology and Intensive Care, , Kyoto Prefectural University of Medicine, ; Kyoto, Japan
                [7 ]ISNI 0000 0004 0467 0255, GRID grid.415020.2, Department of Anesthesiology and Critical Care Medicine, , Jichi Medical University Saitama Medical Center, ; Saitama, Japan
                [8 ]ISNI 0000 0004 0596 6533, GRID grid.411102.7, Department of anesthesiology, , Kobe University Hospital, ; Kobe, Japan
                Article
                Publisher ID: 321
                DOI: 10.1186/s40560-018-0321-9
                PMC ID: 6109298
                PubMed ID: 30155260
                SO-VID: b24c801e-0720-4add-91ed-77efa93ae05b
                Copyright © © The Author(s). 2018
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 4 May 2018
                Date accepted : 7 August 2018
                Categories
                Subject: Letter to the Editor
                Custom metadata
                issue-copyright-statement © The Author(s) 2018

                Keywords: adult respiratory distress syndrome,glucocorticoid treatment,methylprednisolone,dosage,duration of treatment,duration of mechanical ventilation,tapering,reconstituted systemic inflammation,survival
                Data availability:
                Keywords: adult respiratory distress syndrome, glucocorticoid treatment, methylprednisolone, dosage, duration of treatment, duration of mechanical ventilation, tapering, reconstituted systemic inflammation, survival

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