• G U Meduri, A S Headley, E Golden, S J Carson, R A Umberger, T Kelso, and E A Tolley.
• Baptist Memorial Hospitals, Veterans Affairs Medical Center, University of Tennessee, Memphis, USA. umeduri@utmem1.utmem.edu
• JAMA. 1998 Jul 8;280(2):159-65.

ContextNo pharmacological therapeutic protocol has been found effective in modifying the clinical course of acute respiratory distress syndrome (ARDS) and mortality remains greater than 50%.ObjectiveTo determine the effects of prolonged methylprednisolone therapy on lung function and mortality in patients with unresolving ARDS.DesignRandomized, double-blind, placebo-controlled trial.SettingMedical intensive care units of 4 medical centers.ParticipantsTwenty-four patients with severe ARDS who had failed to improve lung injury score (LIS) by the seventh day of respiratory failure.InterventionsSixteen 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.Main Outcome MeasuresPrimary 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.ResultsPhysiological 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.ConclusionsIn 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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