Thoracoscopy Versus Fibrinolysis in Children With Empyema

Empyema Clinical Trial

Official title:

Thoracoscopy Versus Fibrinolysis in Children With Empyema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323531
• Other study ID #: 06 01-019
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 8, 2006
• Last updated: May 6, 2008
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema

Intervention

Procedure:
• Chest tube with tPA infusion for 3 days
fibrinolysis through the chest tube
• VATS decortication
thoracoscopic decortication

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization after intervention		1 month	No
Secondary	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	No