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- Conditions
- Health Condition 1: null- Children suffering from empyema thoracicHealth Condition 2: J90- Pleural effusion, not elsewhere classified
- Registration Number
- CTRI/2018/03/012403
- Lead Sponsor
- Centre for advance Research Rajiv Gandhi University of Health Sciences Karnataka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
1.Diagnosis of Empyema with pleural fluid showing
a)Frank pus appearance or
b)organisms in grams stain
and
2.Evidence of septations or loculations and pleural thickening on chest X-ray and Ultrasound thorax.
1.Resolution of Empyema with initial intercostal drainage
2.Previous history of hypersensitivity to fibrinolytics
3.Complicated pneumonia (Organized empyema with thick peel, lung abscess, Necrotizing pneumonia, Bronchopleural fistula)
4.Bleeding diathesis
5.Immunocompromized status
6.Associated major co-morbid condition/s as determined by clinician
7.Air leak after ICD insertion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of each therapy <br/ ><br>Treatment efficacy of each arm of study in terms of <br/ ><br>duration for clinical recovery, <br/ ><br>ICD days, <br/ ><br>analgesia requirement, and <br/ ><br>intensive care requirements. <br/ ><br>Cost analysis <br/ ><br>Length of hospital stay <br/ ><br>Timepoint: Immediate post therapy 30 days 6 months
- Secondary Outcome Measures
Name Time Method Microbiology of pleural fluid- yield and incidence of organisms <br/ ><br>Long term complications <br/ ><br>Determination of criteria for CT scan <br/ ><br>Antibiotic guidelines to institute for management of empyema <br/ ><br>Primary role of chest tube drainage only for empyema management. <br/ ><br>Need for blood transfusion <br/ ><br>Timepoint: 30 days