Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion (NCT03716375) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion
80 participantsStarted 2018-11
Plain-language summary
Intrapleural administration of fibrinolytic therapy, urokinase in parapneumonic effusion and empyema has been shown to decrease the need for surgical intervention and length of hospital stay. Pleural adhesions are easily formed in the early stages of empyema and the thickening of the pleural causes subsequent treatment difficulties. The goal of this study was to observe and compare the efficacy of treatment in empyema patients with urokinase and chest drainage or with chest drainage or with chest tube drainage alone so as to provide evidence for guiding clinical treatment.
Who can participate
Age range1 Month – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pleural Empyema diagnostic criteria were based on the "Zhu Futang Practical Pediatrics" (the 7th Edition) and The American Thoracic Society consensus guidelines for management of empyema.
* Frank pus at tapping or organism demonstrated on Gram stain or culture
* Pleural fluid pH \< 7.2, glucose \< 60mg/dl, LDH\>1000 IU/ml, protein \> 3g/ml and white cells 15,000 cells/mm cube
* Physical, radiological and laboratory signs accompanying the relevant clinical picture
Inclusion Criteria:
* Previously healthy child with age between 1 month to 18 years
* Admitted with diagnosis of Pleural empyema requiring chest tube insertion and fibrinolytics (as judged by the attending physician) with the following criteria:
I. Pneumonia with pleural empyema based on chest ultrasound and CT scan. II. Need for further intervention based on clinical criteria (persistent fever despite antibiotics for at least 48 hours, significant respiratory distress, tachypnea or hypoxia as a result of pleural empyema.
Exclusion Criteria:
Subject will be excluded if she or he has one of the followings:
* Empyema as result of tuberculosis, fungus or noninfectious causes (e.g. malignancy)
* Known coagulation impairment
* Suspected allergy to urokinase
* Child has already undergone drainage procedure or drug was used in 30 days (e.g.
chest tube or VATS
* Chronic lung diseases or other chronic illnesses (e.g. Immunodeficiency, neurological impairment possible)
* Significant thoracic trauma in last 2 months
* …