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Thoracoscopy Versus Fibrinolysis in Children With Empyema

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.
 
ClinicalTrials.gov Identifier: NCT00323531
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date May 9, 2008
Study Start Date  ICMJE March 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
Length of hospitalization after intervention [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
Days to meeting discharge criteria after intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracoscopy Versus Fibrinolysis in Children With Empyema
Official Title  ICMJE Thoracoscopy Versus Fibrinolysis in Children With Empyema
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Empyema
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2007)
36
Original Enrollment  ICMJE
 (submitted: May 8, 2006)
40
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323531
Other Study ID Numbers  ICMJE 06 01-019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shawn St. Peter, Children's Mercy Hospital
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date May 2008

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