Randomized Controlled Trial of Urokinase versus Placebo for Nondraining Malignant Pleural Effusion

Patients with malignant pleural effusion experience breathlessness, which is treated by drainage and pleurodesis. Incomplete drainage results in residual dyspnea and pleurodesis failure. Intrapleural fibrinolytics lyse septations within pleural fluid, improving drainage. To assess the effects of int...

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Bibliographic Details
Published in:American journal of respiratory and critical care medicine 2018-02, Vol.197 (4), p.502-508
Main Authors: Mishra, Eleanor K, Clive, Amelia O, Wills, Genevieve H, Davies, Helen E, Stanton, Andrew E, Al-Aloul, Mohamed, Hart-Thomas, Alan, Pepperell, Justin, Evison, Matthew, Saba, Tarek, Harrison, Richard Neil, Guhan, Anur, Callister, Matthew E, Sathyamurthy, Ramamurthy, Rehal, Sunita, Corcoran, John P, Hallifax, Robert, Psallidas, Ioannis, Russell, Nicky, Shaw, Rachel, Dobson, Melissa, Wrightson, John M, West, Alex, Lee, Y C Gary, Nunn, Andrew J, Miller, Robert F, Maskell, Nick A, Rahman, Najib M
Format: Article
Language:English
Subjects:
Aged
Cancer therapies
Catheters
Chemotherapy
Clinical trials
Double-Blind Method
Dyspnea
Evidence-based medicine
Female
Hospitals
Humans
Infections
Length of Stay - statistics & numerical data
Male
Medical prognosis
Medical research
Palliative Care - methods
Pleural Effusion, Malignant - enzymology
Pleural Effusion, Malignant - therapy
Pleurodesis - methods
Prospective Studies
Regulatory approval
Success
Ultrasonic imaging
Urokinase-Type Plasminogen Activator - therapeutic use
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Summary:Patients with malignant pleural effusion experience breathlessness, which is treated by drainage and pleurodesis. Incomplete drainage results in residual dyspnea and pleurodesis failure. Intrapleural fibrinolytics lyse septations within pleural fluid, improving drainage. To assess the effects of intrapleural urokinase on dyspnea and pleurodesis success in patients with nondraining malignant effusion. We conducted a prospective, double-blind, randomized trial. Patients with nondraining effusion were randomly allocated in a 1:1 ratio to intrapleural urokinase (100,000 IU, three doses, 12-hourly) or matched placebo. Co-primary outcome measures were dyspnea (average daily 100-mm visual analog scale scores over 28 d) and time to pleurodesis failure to 12 months. Secondary outcomes were survival, hospital length of stay, and radiographic change. A total of 71 subjects were randomized (36 received urokinase, 35 placebo) from 12 U.K. centers. The baseline characteristics were similar between the groups. There was no difference in mean dyspnea between groups (mean difference, 3.8 mm; 95% confidence interval [CI], -12 to 4.4 mm; P = 0.36). Pleurodesis failure rates were similar (urokinase, 13 of 35 [37%]; placebo, 11 of 34 [32%]; adjusted hazard ratio, 1.2; P = 0.65). Urokinase was associated with decreased effusion size visualized by chest radiography (adjusted relative improvement, -19%; 95% CI, -28 to -11%; P 
ISSN:1073-449X
1535-4970
DOI:10.1164/rccm.201704-0809OC