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Sponsored by: |
Children's Mercy Hospital Kansas City |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00323531 |
The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. Therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.
Condition | Intervention | Phase |
---|---|---|
Empyema |
Procedure: Chest tube with tPA infusion for 3 days Procedure: VATS decortication |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Thoracoscopy Versus Fibrinolysis in Children With Empyema |
Enrollment: | 36 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Video assisted thoracoscopic decortication
|
Procedure: VATS decortication
thoracoscopic decortication
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2: Experimental
Fibrinolysis through the chest tube
|
Procedure: Chest tube with tPA infusion for 3 days
fibrinolysis through the chest tube
|
This will be a single institution, prospective, randomized clinical trial involving patients who are found to have at least a single septation within a pleural effusion as diagnosed by ultrasound or computed tomography. Additionally, patients with a pleural effusion wherein a pleural tap reveals pus as defined by many (> 10,000/mm3 ) white blood cells or positive cultures will be considered. This is intended to be a definitive study.
Power calculations based on the known 4.8 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α = 0.05 and power of 0.8 show the need for 18 patients in each arm. We will intend to recruit 40. This sample size was constructed in consultation with Dr. Steve Simon, and the range of hospital stay in our retrospective experience was utilized. Therefore, this number should represent an adequate power in spite of the known varied level of illness.
One group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage. The other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage.
Both groups will have the same antibiotic regimen with the same management algorithm.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients less than 18 years of age requiring an intervention for empyema by one of the following:
Exclusion Criteria:
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Shawn D St. Peter, MD | Children's Mercy Hospital |
Responsible Party: | Children's Mercy Hospital ( Shawn St. Peter ) |
Study ID Numbers: | 06 01-019 |
Study First Received: | May 8, 2006 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00323531 |
Health Authority: | United States: Institutional Review Board |
thoracoscopy fibrinolysis empyema children |
Suppuration Empyema Inflammation |
Pathologic Processes Infection |