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Thoracoscopy Versus Fibrinolysis in Children With Empyema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323531
First Posted: May 9, 2006
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Mercy Hospital Kansas City
May 8, 2006
May 9, 2006
May 9, 2008
March 2006
October 2007   (Final data collection date for primary outcome measure)
Length of hospitalization after intervention [ Time Frame: 1 month ]
Days to meeting discharge criteria after intervention
Complete list of historical versions of study NCT00323531 on ClinicalTrials.gov Archive Site
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 ]
Days where a maximum temperature was equal to or above 38C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges
Not Provided
Not Provided
 
Thoracoscopy Versus Fibrinolysis in Children With Empyema
Thoracoscopy Versus Fibrinolysis in Children With Empyema
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Empyema
  • Procedure: Chest tube with tPA infusion for 3 days
    fibrinolysis through the chest tube
    Other Names:
    • Fibrinolysis
    • tPA
  • Procedure: VATS decortication
    thoracoscopic decortication
    Other Names:
    • VATS
    • pleural debridement
  • Active Comparator: 1
    Video assisted thoracoscopic decortication
    Intervention: Procedure: VATS decortication
  • Experimental: 2
    Fibrinolysis through the chest tube
    Intervention: Procedure: Chest tube with tPA infusion for 3 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients less than 18 years of age requiring an intervention for empyema by one of the following:

    1. Septation or loculation seen on ultrasound or computed tomography
    2. Many white blood cells, bacteria present, or thick viscid purulence identified on pleural tap

Exclusion Criteria:

  1. Immunodeficiency process
  2. Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
  3. Existing contraindications to VATS or chest tube.
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00323531
06 01-019
No
Not Provided
Not Provided
Shawn St. Peter, Children's Mercy Hospital
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP