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Am. J. Respir. Crit. Care Med. · May 2022
Randomized Controlled Trial Multicenter StudyThe Steroid Therapy and Outcome of Parapneumonic Pleural Effusions (STOPPE): A Pilot Randomized Trial.
- Deirdre B Fitzgerald, Grant W Waterer, Charley Budgeon, Ranjan Shrestha, Edward T Fysh, Sanjeevan Muruganandan, Christopher Stanley, Tajalli Saghaie, Arash Badiei, Calvin Sidhu, Hilman Harryanto, Victor Duong, Maree Azzopardi, David Manners, LanNorris S HNSHRespiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia., Natalia D Popowicz, Carolyn J Peddle-McIntyre, Najib M Rahman, Catherine A Read, Ai Ling Tan, Seng Khee Gan, Kevin Murray, and LeeY C GaryYCG0000-0002-0036-511XRespiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.Medical School, Faculty of Health and Medical Sciences.Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Aus.
- Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
- Am. J. Respir. Crit. Care Med. 2022 May 1; 205 (9): 109311011093-1101.
AbstractRationale: 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 Measurements and Main Results: Eighty patients were randomized (one withdrawn before treatment) and received dexamethasone (n = 51) or placebo (n = 28).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).
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