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Thoracoscopy Versus Fibrinolysis in Children With Empyema

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00323531
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
19
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Chest tube with tPA infusion for 3 days
  • Procedure: VATS decortication
 Phase 2/Phase 3

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Thoracoscopy Versus Fibrinolysis in Children With Empyema
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Video assisted thoracoscopic decortication

Procedure: VATS decortication
thoracoscopic decortication
Other Names:
  • VATS
  • pleural debridement

    		•
    Experimental: 2

    Fibrinolysis through the chest tube

    Procedure: Chest tube with tPA infusion for 3 days
    fibrinolysis through the chest tube
    Other Names:
  • Fibrinolysis
  • tPA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Length of hospitalization after intervention [1 month]

    Secondary Outcome Measures

    1. 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 [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City

    Investigators

    • Principal Investigator: Shawn D St. Peter, MD, Children's Mercy Hospital Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00323531
    Other Study ID Numbers:
    • 06 01-019
    First Posted:
    May 9, 2006
    Last Update Posted:
    May 9, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    thoracoscopy
    fibrinolysis
    empyema
    children
    Additional relevant MeSH terms:
    Empyema

    Study Results

    No Results Posted as of May 9, 2008