Effect of Prolonged Methylprednisolone Therapy in Unresolving Acute Respiratory Distress Syndrome
- 8 July 1998
- journal article
- clinical trial
- Published by American Medical Association (AMA) in JAMA
- Vol. 280 (2) , 159-165
- https://doi.org/10.1001/jama.280.2.159
Abstract
Research from JAMA — Effect of Prolonged Methylprednisolone Therapy in Unresolving Acute Respiratory Distress Syndrome — A Randomized Controlled Trial — Context.—No pharmacological therapeutic protocol has been found effective in modifying the clinical course of acute respiratory distress syndrome (ARDS) and mortality remains greater than 50%.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.—Twenty-four patients with severe ARDS who had failed to improve lung injury score (LIS) by the seventh day of respiratory failure.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.—Primary 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.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.Keywords
This publication has 20 references indexed in Scilit:
- Infections and the Inflammatory Response in Acute Respiratory Distress SyndromeChest, 1997
- The acute respiratory distress syndrome: Definitions, severity and clinical outcome An analysis of 101 clinical investigationsIntensive Care Medicine, 1996
- Established Adult Respiratory Distress Syndrome Successfully Treated With CorticosteroidsSouthern Medical Journal, 1996
- Are corticosteroids salvage therapy for refractory acute respiratory distress syndrome?The American Journal of Surgery, 1995
- Plasma and BAL Cytokine Response to Corticosteroid Rescue Treatment in Late ARDSChest, 1995
- Pharmacokinetics of Methylprednisolone in Elderly and Young Healthy MalesJournal of the American Geriatrics Society, 1994
- Causes of Fever and Pulmonary Densities in Patients with Clinical Manifestations of Ventilator-Associated PneumoniaChest, 1994
- The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination.American Journal of Respiratory and Critical Care Medicine, 1994
- An Expanded Definition of the Adult Respiratory Distress SyndromeAmerican Review of Respiratory Disease, 1988
- High-Dose Corticosteroids in Patients with the Adult Respiratory Distress SyndromeNew England Journal of Medicine, 1987