Abstract | CONTEXT: OBJECTIVE: To determine the effects of prolonged methylprednisolone therapy on lung function and mortality in patients with unresolving ARDS. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Medical intensive care units of 4 medical centers. PARTICIPANTS: INTERVENTIONS: 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. MAIN OUTCOME MEASURES: RESULTS: 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. CONCLUSIONS: 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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Authors | G U Meduri, A S Headley, E Golden, S J Carson, R A Umberger, T Kelso, E A Tolley |
Journal | JAMA
(JAMA)
Vol. 280
Issue 2
Pg. 159-65
(Jul 08 1998)
ISSN: 0098-7484 [Print] United States |
PMID | 9669790
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Methylprednisolone
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Topics |
- Adult
- Anti-Inflammatory Agents
(therapeutic use)
- Cross Infection
(etiology)
- Double-Blind Method
- Female
- Hospital Mortality
- Humans
- Intensive Care Units
- Male
- Methylprednisolone
(therapeutic use)
- Middle Aged
- Multiple Organ Failure
(etiology)
- Prospective Studies
- Respiratory Distress Syndrome
(complications, drug therapy)
- Respiratory Function Tests
- Severity of Illness Index
- Survival Analysis
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