Chest
Volume 92, Issue 6, December 1987, Pages 1032-1036
Journal home page for Chest

Early Methylprednisolone Treatment for Septic Syndrome and the Adult Respiratory Distress Syndrome

https://doi.org/10.1378/chest.92.6.1032Get rights and content

From November 1, 1982 through December 31, 1985, there were 19 centers and 382 patients that evaluated the effect of methylprednisolone sodium succinate (MPSS) on the septic syndrome. Seventeen of these centers enrolled 304 patients in a prospective, randomized, double-blind, placebo-controlled study to determine if early treatment with MPSS would decrease the incidence of severity of the adult respiratory distress syndrome (ARDS) in patients at risk of ARDS from sepsis. To ensure early institution of the MPSS or placebo therapy (PLA), patients with the presumptive diagnosis of sepsis were identified. That diagnosis was based on the presence of fever or hypothermia (temperature >38.3°C or <35.5°C, rectal), tachypnea (>20 bpm), tachycardia (>90 bpm) and the presence of one of the following indices of organ dysfunction: a change in mental status, hypoxemia, elevated lactate levels or oliguria. The treatment, either MPSS 30 mg/kg or PLA, was given in four 20-minute infusions six hours apart and was initiated within two hours of the presumptive diagnosis of sepsis. The development and reversal of the adult respiratory distress syndrome (ARDS) was followed and resulted in data on 304 of the 382 randomized patients. A trend toward increased incidence of ARDS was seen in the MPSS group 50/152 (32 percent) compared to the placebo group 38/152(25 percent) p = 0.10. Significantly fewer MPSS patients reversed their ARDS 15/50 (31 percent) compared to placebo 23/38 (61 percent) p = 0.005. The 14-day mortality in patients with ARDS treated with MPSS was 26/50 (52 percent) compared to placebo 8/22 (22 percent) p = 0.004. We conclude that early treatment of septic syndrome with MPSS does not prevent the development of ARDS. Additionally, MPSS treatment impedes the reversal of ARDS and increases the mortality rate in patients with ARDS.

Section snippets

METHODS

This study was conducted at 17 centers throughout the United States. The project began on November 1, 1982. The study was concluded on December 31, 1985.

RESULTS

Three hundred four patients with the presumptive diagnosis of severe sepsis were enrolled in this study. Patient diagnosis, age, sex, and disease severity of the patients developing ARDS are shown in Table 1 for the MPSS and placebo patients. The mean age of patients who developed ARDS receiving MPSS was 56.7 ± 15.5 compared to placebo which was 53.3 ± 15.4. The development of ARDS was not influenced by the presence or absence of bacteremia. If the patient was judged to have an ultimately fatal

DISCUSSION

The adult respiratory distress syndrome is a clinical syndrome of undetermined etiology characterized by pulmonary and multiorgan system failure that occurs in the wake of a diverse array of systemic insults such as hypotension, sepsis, trauma, or many others. This clinical form of acute lung injury is important in that it affects 100,000 to 300,000 persons per year in the United States. The mortality with optimal supportive therapy today remains around 50-60 percent, unchanged from that

References (0)

Cited by (300)

  • What Works in a Patient With Acute Respiratory Distress Syndrome?

    2022, Evidence-Based Practice of Anesthesiology
  • Use of glucocorticoids in the critical care setting: Science and clinical evidence

    2020, Pharmacology and Therapeutics
    Citation Excerpt :

    The use of early, high doses, and very brief period of GC in patients with septic shock was found to be ineffective in preventing or ameliorating ARDS and probably increased mortality (Bernard et al., 1987; Luce et al., 1988). Bone and colleagues (Bone, Fisher, Clemmer, Slotman, & Metz, 1987) performed a randomized, double-blind placebo-controlled study on the use of early GC for patients with presumed sepsis to determine if ARDS could be prevented. Methylprednisolone at 30 mg kg or placebo was begun within two hours of presumed sepsis scheduled every six hours for four doses.

  • Steroids and Survival in Critically Ill Adult Patients: A Meta-analysis of 135 Randomized Trials

    2018, Journal of Cardiothoracic and Vascular Anesthesia
    Citation Excerpt :

    Eighty-nine studies then were excluded, mostly because they lacked mortality data. Ultimately, the authors identified 135 articles7,8,17–147 including 44,553 patients for the analyses: 22,160 were treated with corticosteroids and 22,160 were in the control group. Of the 135 RCTs, 127 (94%) were conducted with a blind trial design.

View all citing articles on Scopus

Manuscript received and accepted October 6.

*

The Methylprednisolone Severe Sepsis Study Group consisted of the following persons and institutions: The Upjohn Company, Kalamazoo, Michigan—Study Coordinating Center: Craig A. Metz, M.S.; George B. Goris, M.D.; Martha S. Hearron, M.P.H. Study Consultant: University of Michigan Medical School, Ann Arbor: John N. Sheagren, M.D. Participants—Participating Centers, Investigators, and Staff: University of Arkansas for Medical Sciences, Little Rock—Roger C. Bone, M.D.† and Robert A. Balk, M.D.; University of California, Davis Medical Center, Sacramento—Charles J. Fisher, Jr., M.D.,† Timothy E. Albertson, M.D., Ph.D. and N. Karen Mondragon, R.N.; LDS Hospital, Salt Lake City—Terry P. Clemmer, M.D.,† Joseph L. Smith, M.D., and Katherine Nyman, R.N.; Rhode Island Hospital, Providence—Gus J. Slotman, M.D.,† Kenneth W. Burchard, M.D., and Annette D'Arezzo; Wake Forrest University Bowman Gray School of Medicine, Winston-Salem—Byron D. McLees, M.D.,† Charles E. McCall, M.D., and Peter Alford, M.D.; SUNY Upstate Medical Center, Syracuse—Michael S. Jastremski, M.D.,† and L. Chelluri, M.D.; Mt. Carmel Mercy Hospital, Detroit—Vinod K. Puri, M.D.,† José Kruse, M.D., and Roderick Boyes, M.D.; Harper Hospital, Detroit—Joseph J. Bander, M.D.;† Cedars-Sinai Medical Center, Los Angeles—Anthony G. Ellrodt, M.D.;† Baylor College of Medicine, Houston—Barry J. Zeluff, M.D.,† Layne O. Gentry, M.D., and R. Russell Martin, M.D.; University of Southern Florida College of Medicine, Tampa—Hussain I. Saba, M.D.,† John F. Breen, M.D., and Alan I. Leibowitz, M.D.; College of Medicine and Dentistry of New Jersey, Newark—James M. Blackwood, M.D.,† George W. Machiedo, M.D., and Maria Soto-Green, M.D.; Ohio State University Medical Center, Columbus—Joseph F. Plouffe;† LSU Medical Center, New Orleans —Charles V Sanders, M.D.,† C. Lynn-Besch, M.D. and Frederick W. Derks, M.D.; Loyola University Stritch School of Medicine, Maywood—Frank R. Venezio, M.D.;† University of Maryland School of Medicine, Baltimore—Ellis S. Caplan, M.D.,† Howard Belzberg, M.D., and Dino Delaportas, M.D.; University of Minnesota Medical School, Minneapolis—Frank B. Cerra, M.D.,† Henry J. Mann, Pharm.D.; Northwestern Memorial Hospital, Chicago—John P. Phair, M.D.,† Richard Davison, M.D., and JoAnne Goldsmith, M.D.

View full text