Back to resultsUrokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Primary Purpose
Empyema, Pneumonia
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Urokinase
Video-Assisted Thoracoscopic
Sponsored by
About this trial
This is an interventional treatment trial for Empyema focused on measuring Empyema, Urokinase, Thoracoscopic, Childhood
Eligibility Criteria
Inclusion Criteria:
- Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain
Exclusion Criteria:
- Existing contraindications or other previous conditions, hypertension, pneumothorax
Sites / Locations
- Hospital Universitario Central de Asturias
- Hospital de Donostia
- University Hospital Vall d'Hebron
- Hospital Gregorio Marañón
- Hospital Infantil La Paz
- Hospital Universitario 12 de Octubre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Urokinase
Thoracoscopic
Arm Description
urokinase infusion for 3 days
Video-Assisted Thoracoscopic
Outcomes
Primary Outcome Measures
duration of the hospital stay after the treatment
Secondary Outcome Measures
complications of the treatment and complications of the disease
total duration of the hospital stay
number of days carrying the chest drain
duration of the fever once the empyema has been drained
Full Information
NCT ID
NCT00798278
First Posted
November 25, 2008
Last Updated
October 27, 2010
Sponsor
Spanish Society of Pediatric Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00798278
Brief Title
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Official Title
Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Spanish Society of Pediatric Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empyema, Pneumonia
Keywords
Empyema, Urokinase, Thoracoscopic, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urokinase
Arm Type
Experimental
Arm Description
urokinase infusion for 3 days
Arm Title
Thoracoscopic
Arm Type
Active Comparator
Arm Description
Video-Assisted Thoracoscopic
Intervention Type
Drug
Intervention Name(s)
Urokinase
Intervention Description
Chest tube with intrapleural urokinase infusion for 3 days
Intervention Type
Procedure
Intervention Name(s)
Video-Assisted Thoracoscopic
Intervention Description
Video-Assisted Thoracoscopic decortication
Primary Outcome Measure Information:
Title
duration of the hospital stay after the treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
complications of the treatment and complications of the disease
Time Frame
3 months
Title
total duration of the hospital stay
Time Frame
3 months
Title
number of days carrying the chest drain
Time Frame
3 months
Title
duration of the fever once the empyema has been drained
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain
Exclusion Criteria:
Existing contraindications or other previous conditions, hypertension, pneumothorax
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastián
State/Province
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Infantil La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
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