Steroid therapy and outcome of parapneumonic pleural effusions (STOPPE): A pilot randomized clinical trial
Abstract
Rationale: Pleural effusion commonly complicates community-acquired pneumonia and is associated with intense pleural inflammation. Whether antiinflammatory treatment with corticosteroids improves outcomes is unknown. Objectives: To assess the effects of corticosteroids in an adult population with pneumonia-related pleural effusion. Methods: The STOPPE (Steroid Therapy and Outcome of Parapneumonic Pleural Effusions) trial was a pilot, multicenter, double-blinded, placebo-controlled, randomized trial involving six Australian centers. Patients with community-acquired pneumonia and pleural effusion were randomized (2:1) to intravenous dexamethasone (4 mg twice daily for 48 h) or placebo and followed for 30 days. Given the diverse effects of corticosteroids, a comprehensive range of clinical, serological, and imaging outcomes were assessed in this pilot trial (ACTRN12618000947202). Measurements and Main Results: Eighty patients were randomized (one withdrawn before treatment) and received dexamethasone (n = 51) or placebo (n = 28). This pilot trial found no preliminary evidence of benefits of dexamethasone in improving time to sustained (>12 h) normalization of vital signs (temperature, oxygen saturations, blood pressure, heart, and respiratory rates): median, 41.0 (95% confidence interval, 32.3-54.5) versus 27.8 (15.4-49.5) hours in the placebo arm (hazard ratio, 0.729 [95% confidence interval, 0.453-1.173]; P = 0.193). Similarly, no differences in C-reactive protein or leukocyte counts were observed, except for a higher leukocyte count in the dexamethasone group at Day 3. Pleural drainage procedures were performed in 49.0% of dexamethasone-treated and 42.9% of placebo-treated patients (P = 0.60). Radiographic pleural opacification decreased over time with no consistent intergroup differences. Mean duration of antibiotic therapy (22.4 [SD, 15.4] vs. 20.4 [SD, 13.8] d) and median hospitalization (6.0 [interquartile range, 5.0-10.0] vs. 5.5 [interquartile range, 5.0-8.0] d) were similar between the dexamethasone and placebo groups. Serious adverse events occurred in 25.5% of dexamethasone-treated and 21.4% of placebo-treated patients. Transient hyperglycemia more commonly affected the dexamethasone group (15.6% vs. 7.1%). Conclusions: Systemic corticosteroids showed no preliminary benefits in adults with parapneumonic effusions. Clinical trial registered with www.anzctr.org.au (ACTRN12618000947202).
Keywords
dexamethasone, pleural effusion, pneumonia, randomized controlled trial, steroid
Document Type
Journal Article
Date of Publication
5-1-2022
Volume
205
Issue
9
PubMed ID
35081010
Publication Title
American journal of respiratory and critical care medicine
Publisher
American Thoracic Society
School
School of Medical and Health Sciences / Exercise Medicine Research Institute
RAS ID
44764
Funders
National Health and Medical Research Council of Australia / European Respiratory Society / Sir Charles Gairdner Research Advisory Committee project grants and Northern Health Foundation / Catholic Health Australia
Copyright
subscription content
First Page
1093
Last Page
1101
Comments
Fitzgerald, D. B., Waterer, G. W., Budgeon, C., Shrestha, R., Fysh, E. T., Muruganandan, S., ... & Lee, Y. G. (2022). The Steroid Therapy and Outcome of Parapneumonic Pleural Effusions (STOPPE): A Pilot Randomized Trial. American Journal of Respiratory and Critical Care Medicine, 205(9). https://doi.org/10.1164/rccm.202107-1600OC