Complicated Pleural Effusion/ Empyema Clinical Trial
Official title:
A Randomized Controlled Study of Fibrinolytic Treatment for Purulent Pleural Effusion in Children
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.
Empyema, a collection of pus in the pleural space has been continuously associated with
morbidity and mortality rates of 10-20%. Increase in the incidence of empyema with change in
pattern of disease and the causative organism has demonstrated a challenge in the diagnosis
and treatment. In the recent years many studies and clinical trials have been done among
adults and children regarding the optimal empyema treatment and its efficacy and some are
still in the process of further study. Appropriate treatment according to the three stages of
empyema (i.e. exudative stage, fibropurulent stage and organizing stage) has constantly been
under frequent research, finding which treatment is more effective (i.e. antibiotics, chest
tube drainage, intrapleural fibrinolytics, VATS and decortication alone in combination) and
when is the proper time for intervention. Intrapleural instillation of urokinase was
initially described in 1994 on pediatric population and since then lots of studies have been
reported. Therefore, the investigators conducted a randomized controlled study with relevant
inclusion and exclusion criteria to assess the success rate of intrapleural urokinase
administration among the patients with Complicated Pleural Effusion (CPE) / empyema comparing
it with drainage alone. All case patients in this study received antibiotic empirically or
with sensitivity when microbiological tests available, chest tube drainage along with
urokinase intrapleural therapy or drainage alone for treatment of CPE/empyema.
Patients will be randomized into two groups: one is chest tube drainage and intrapleural
fibrinolytic agent and another is chest tube drainage alone. The group with intrapleural
fibrinolytic agent will receive urokinase 10ml of 1000 IU/ml in children aged less than or
equal to 1 year or 40ml of 1000 IU/ml in children aged more than 1 year and the other group
with drainage alone. The first instillation of the agent is done at the time of chest tube
insertion of 12Fr or 14Fr tube, after instillation the chest tube is closed for 4 hours. The
chest tube is then unclamped after 4 hours and connected to the suction system with pressure
of -20cm H2O for 8 hours and the process is repeated every 12 hourly. The procedure was done
for 3 consecutive days and was evaluated with daily chest X-ray and followed chest tube
removal when the drainage was less than 40ml/day or according to the clinical and
radiological response of patients with treatment.
The trial is being done for 12 months with 80 participants taken from one center, Beijing
children´s Hospital.
The aim of this study is to evaluate difference among intrapleural urokinase as the initial
treatment for children with pleural empyema against chest tube drainage alone. Length of
hospital stay, number of days chest tube drainage, number of days of fever after tube
insertion, complications such bleeding, chest pain will be compared between the two groups.
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