Thoracoscopy Versus Fibrinolysis in Children With Empyema

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00323531
First received: May 8, 2006
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thoracoscopy Versus Fibrinolysis in Children With Empyema

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of hospitalization after intervention [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323531

Locations
United States, Missouri
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
  More Information

No publications provided

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00323531     History of Changes
Other Study ID Numbers: 06 01-019
Study First Received: May 8, 2006
Last Updated: May 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
thoracoscopy
fibrinolysis
empyema
children

Additional relevant MeSH terms:
Empyema
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014