Title

Steroid therapy and outcome of parapneumonic pleural effusions (STOPPE): A pilot randomized clinical trial

Document Type

Journal Article

Publication Title

American journal of respiratory and critical care medicine

Volume

205

Issue

9

First Page

1093

Last Page

1101

PubMed ID

35081010

Publisher

American Thoracic Society

School

School of Medical and Health Sciences / Exercise Medicine Research Institute

RAS ID

31161

Funders

National Health and Medical Research Council of Australia European Respiratory Society Sir Charles Gairdner Research Advisory Committee project grants and Northern Health Foundation

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

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 Measurements and Main Results: Eighty patients were randomized (one withdrawn before treatment) and received dexamethasone (n = 51) or placebo (n = 28).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).

DOI

10.1164/rccm.202107-1600OC

Access Rights

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Research Themes

Health

Priority Areas

Prevention, detection and management of cancer and other chronic diseases

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