Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion
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|ClinicalTrials.gov Identifier: NCT03716375|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Complicated Pleural Effusion/ Empyema||Drug: Intrapleural Medications||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Study of Fibrinolytic Treatment for Purulent Pleural Effusion in Children|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: use of fibrinolytic agent
Chest tube drainage with intrapleural urokinase instillation 1000 IU/ml
Drug: Intrapleural Medications
No Intervention: no use of any drug
Chest tube drainage
- Length of hospital stay [ Time Frame: 2 weeks ]
- Days of fever after chest tube insertion [ Time Frame: 3 to 4 days ]
- Duration of drainage [ Time Frame: 2 weeks ]
- Complications [ Time Frame: 2weeks ]number of participants changed to open thoracotomy
- Failure rate [ Time Frame: 2weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716375
|Contact: Xu Baoping, MD, PhDfirstname.lastname@example.org|
|Principal Investigator:||Xu Baoping, MD, PhD||Beijings Children´s Hospital of Capital Medical University, China|