Thoracoscopy Versus Fibrinolysis in Children With Empyema

May 6, 2008 updated by: Children's Mercy Hospital Kansas City
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • tPA
  • Fibrinolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospitalization after intervention
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (ESTIMATE)

May 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06 01-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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