Thoracoscopy Versus Fibrinolysis in Children With Empyema
|ClinicalTrials.gov Identifier: NCT00323531|
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : May 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Empyema||Procedure: Chest tube with tPA infusion for 3 days Procedure: VATS decortication||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thoracoscopy Versus Fibrinolysis in Children With Empyema|
|Study Start Date :||March 2006|
|Primary Completion Date :||October 2007|
|Study Completion Date :||October 2007|
Active Comparator: 1
Video assisted thoracoscopic decortication
Procedure: VATS decortication
Fibrinolysis through the chest tube
Procedure: Chest tube with tPA infusion for 3 days
fibrinolysis through the chest tube
- Length of hospitalization after intervention [ Time Frame: 1 month ]
- Days where a maximum temperature was equal to or above 38 degrees C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323531
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital|