We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00323531     History of Changes
Other Study ID Numbers: 06 01-019
First Submitted: May 8, 2006
First Posted: May 9, 2006
Last Update Posted: May 9, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Empyema
Suppuration
Infection
Inflammation
Pathologic Processes


To Top