Thoracoscopy Versus Fibrinolysis in Children With Empyema - Tabular View

Tracking Information

First Received Date ^ICMJE

May 8, 2006

Last Updated Date

May 6, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Days to meeting discharge criteria after intervention

Change History

Complete list of historical versions of study NCT00323531 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Empyema

Intervention ^ICMJE

Procedure: Chest tube with tPA infusion for 3 days
Procedure: VATS decortication

Study Arms / Comparison Groups

Active Comparator: Video assisted thoracoscopic decortication
Experimental: Fibrinolysis through the chest tube

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

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:

Immunodeficiency process
Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
Existing contraindications to VATS or chest tube.

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00323531

Responsible Party

Shawn St. Peter, Children's Mercy Hospital

Study ID Numbers ^ICMJE

06 01-019

Study Sponsor ^ICMJE

Children's Mercy Hospital Kansas City

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Shawn D St. Peter, MD

Children's Mercy Hospital

Information Provided By

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