- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716375
Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion
A Randomized Controlled Study of Fibrinolytic Treatment for Purulent Pleural Effusion in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xu Baoping, MD, PhD
- Phone Number: +861059616308
- Email: xubaopingbch@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Severe arterial hypertension
- Presence of Pneumothorax before treatment (i.e. bronchopleural fistula)
- Pregnancy
- Breast feeding
- Poor compliance
- Contraindication in the presence of fibrinolytic agent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: use of fibrinolytic agent
Chest tube drainage with intrapleural urokinase instillation 1000 IU/ml
|
urokinase
|
No Intervention: no use of any drug
Chest tube drainage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of fever after chest tube insertion
Time Frame: 3 to 4 days
|
3 to 4 days
|
|
Duration of drainage
Time Frame: 2 weeks
|
2 weeks
|
|
Complications
Time Frame: 2weeks
|
number of participants changed to open thoracotomy
|
2weeks
|
Failure rate
Time Frame: 2weeks
|
2weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xu Baoping, MD, PhD, Beijings Children´s Hospital of Capital Medical University, China
Publications and helpful links
General Publications
- Shirota C, Uchida H. Initial treatment of septated parapneumonic empyema with drainage plus fibrinolytic agents is equally effective as video-assisted thoracoscopic surgery, and is suitable as first-line therapy. Transl Pediatr. 2015 Jan;4(1):41-4. doi: 10.3978/j.issn.2224-4336.2015.02.01.
- Stefanutti G, Ghirardo V, Barbato A, Gamba P. Evaluation of a pediatric protocol of intrapleural urokinase for pleural empyema: a prospective study. Surgery. 2010 Sep;148(3):589-94. doi: 10.1016/j.surg.2010.01.010. Epub 2010 Mar 20.
- Walker W, Wheeler R, Legg J. Update on the causes, investigation and management of empyema in childhood. Arch Dis Child. 2011 May;96(5):482-8. doi: 10.1136/adc.2009.165357. Epub 2010 Aug 24.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCHlung011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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