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Randomized Controlled Trial
. 2006 Apr 20;354(16):1671-84.
doi: 10.1056/NEJMoa051693.

Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome

Kenneth P Steinberg  1 , Leonard D Hudson, Richard B Goodman, Catherine Lee Hough, Paul N Lanken, Robert Hyzy, B Taylor Thompson, Marek Ancukiewicz; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network
Affiliations
Free article
Randomized Controlled Trial

Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome

Kenneth P Steinberg et al. N Engl J Med. .
Free article

Abstract

Background: Persistent acute respiratory distress syndrome (ARDS) is characterized by excessive fibroproliferation, ongoing inflammation, prolonged mechanical ventilation, and a substantial risk of death. Because previous reports suggested that corticosteroids may improve survival, we performed a multicenter, randomized controlled trial of corticosteroids in patients with persistent ARDS.

Methods: We randomly assigned 180 patients with ARDS of at least seven days' duration to receive either methylprednisolone or placebo in a double-blind fashion. The primary end point was mortality at 60 days. Secondary end points included the number of ventilator-free days and organ-failure-free days, biochemical markers of inflammation and fibroproliferation, and infectious complications.

Results: At 60 days, the hospital mortality rate was 28.6 percent in the placebo group (95 percent confidence interval, 20.3 to 38.6 percent) and 29.2 percent in the methylprednisolone group (95 percent confidence interval, 20.8 to 39.4 percent; P=1.0); at 180 days, the rates were 31.9 percent (95 percent confidence interval, 23.2 to 42.0 percent) and 31.5 percent (95 percent confidence interval, 22.8 to 41.7 percent; P=1.0), respectively. Methylprednisolone was associated with significantly increased 60- and 180-day mortality rates among patients enrolled at least 14 days after the onset of ARDS. Methylprednisolone increased the number of ventilator-free and shock-free days during the first 28 days in association with an improvement in oxygenation, respiratory-system compliance, and blood pressure with fewer days of vasopressor therapy. As compared with placebo, methylprednisolone did not increase the rate of infectious complications but was associated with a higher rate of neuromuscular weakness.

Conclusions: These results do not support the routine use of methylprednisolone for persistent ARDS despite the improvement in cardiopulmonary physiology. In addition, starting methylprednisolone therapy more than two weeks after the onset of ARDS may increase the risk of death. (ClinicalTrials.gov number, NCT00295269.).

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Comment in

  • Lung Inflammation in ARDS--friend or foe?
    Suter PM. Suter PM. N Engl J Med. 2006 Apr 20;354(16):1739-42. doi: 10.1056/NEJMe068033. N Engl J Med. 2006. PMID: 16625013 No abstract available.
  • Corticosteroids in ARDS.
    Marik P, Pastores S, Annane D. Marik P, et al. N Engl J Med. 2006 Jul 20;355(3):316-7; author reply 318-9. doi: 10.1056/NEJMc066215. N Engl J Med. 2006. PMID: 16855276 No abstract available.
  • Corticosteroids in ARDS.
    DiNubile MJ. DiNubile MJ. N Engl J Med. 2006 Jul 20;355(3):317-8; author reply 318-9. N Engl J Med. 2006. PMID: 16856285 No abstract available.
  • Corticosteroids in ARDS.
    Speich R, Schmid C, Stocker R. Speich R, et al. N Engl J Med. 2006 Jul 20;355(3):317; author reply 318-9. N Engl J Med. 2006. PMID: 16858835 No abstract available.
  • Corticosteroids in ARDS.
    Okamoto H. Okamoto H. N Engl J Med. 2006 Jul 20;355(3):317; author reply 318-9. N Engl J Med. 2006. PMID: 16858836 No abstract available.
  • Fluid-management strategies in acute lung injury.
    Morizio A, Kupfer Y, Tessler S. Morizio A, et al. N Engl J Med. 2006 Sep 14;355(11):1175; author reply 1176. N Engl J Med. 2006. PMID: 16977702 No abstract available.
  • Steroids in late ARDS?
    Wajanaponsan N, Reade MC, Milbrandt EB. Wajanaponsan N, et al. Crit Care. 2007;11(4):310. doi: 10.1186/cc5954. Crit Care. 2007. PMID: 17666114 Free PMC article. No abstract available.
  • Steroids in fibroproliferative acute respiratory distress syndrome: approach with care.
    Ewanchuk MA, Jacka MJ. Ewanchuk MA, et al. Can J Anaesth. 2007 Sep;54(9):765-6. doi: 10.1007/BF03026873. Can J Anaesth. 2007. PMID: 17766744 No abstract available.

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