Methylprednisolone infusion in early severe ARDS: results of a randomized controlled trial

Chest. 2007 Apr;131(4):954-63. doi: 10.1378/chest.06-2100.


Objective: To determine the effects of low-dose prolonged methylprednisolone infusion on lung function in patients with early severe ARDS.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: ICUs of five hospitals in Memphis.

Participants: Ninety-one patients with severe early ARDS (</= 72 h), 66% with sepsis.

Interventions: Patients were randomized (2:1 fashion) to methylprednisolone infusion (1 mg/kg/d) vs placebo. The duration of treatment was up to 28 days. Infection surveillance and avoidance of paralysis were integral components of the protocol.

Main outcome measure: The predefined primary end point was a 1-point reduction in lung injury score (LIS) or successful extubation by day 7.

Results: In intention-to-treat analysis, the response of the two groups (63 treated and 28 control) clearly diverged by day 7, with twice the proportion of treated patients achieving a 1-point reduction in LIS (69.8% vs 35.7%; p = 0.002) and breathing without assistance (53.9% vs 25.0%; p = 0.01). Treated patients had significant reduction in C-reactive protein levels, and by day 7 had lower LIS and multiple organ dysfunction syndrome scores. Treatment was associated with a reduction in the duration of mechanical ventilation (p = 0.002), ICU stay (p = 0.007), and ICU mortality (20.6% vs 42.9%; p = 0.03). Treated patients had a lower rate of infections (p = 0.0002), and infection surveillance identified 56% of nosocomial infections in patients without fever.

Conclusions: Methylprednisolone-induced down-regulation of systemic inflammation was associated with significant improvement in pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and ICU length of stay.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • C-Reactive Protein / metabolism
  • Catecholamines / blood
  • Dose-Response Relationship, Drug
  • Female
  • Fluorescence Polarization Immunoassay
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage*
  • Hospital Mortality
  • Humans
  • Hydrocortisone / blood
  • Infusions, Intravenous
  • Length of Stay
  • Male
  • Methylprednisolone / administration & dosage*
  • Middle Aged
  • Respiration, Artificial
  • Respiratory Care Units
  • Respiratory Distress Syndrome / blood
  • Respiratory Distress Syndrome / mortality
  • Respiratory Distress Syndrome / therapy*
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome


  • Catecholamines
  • Glucocorticoids
  • C-Reactive Protein
  • Hydrocortisone
  • Methylprednisolone