Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

Phase 3

Completed

• Conditions: Empyema; Pneumonia
• Interventions: Drug: Urokinase; Procedure: Video-Assisted Thoracoscopic

• Registration Number: NCT00798278
• Lead Sponsor: Spanish Society of Pediatric Surgery

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Existing contraindications or other previous conditions, hypertension, pneumothorax

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urokinase	Urokinase	urokinase infusion for 3 days
Thoracoscopic	Video-Assisted Thoracoscopic	Video-Assisted Thoracoscopic

Primary Outcome Measures

Name	Time	Method
duration of the hospital stay after the treatment	3 months

Secondary Outcome Measures

Name	Time	Method
complications of the treatment and complications of the disease	3 months
total duration of the hospital stay	3 months
number of days carrying the chest drain	3 months
duration of the fever once the empyema has been drained	3 months

Trial Locations

Locations (6)

Hospital Infantil La Paz; 🇪🇸 Madrid, Spain

Hospital de Donostia; 🇪🇸 San Sebastián, Donostia, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain