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

Sponsor

Spanish Society of Pediatric Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT00798278

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Empyema Pneumonia	Drug: Urokinase Procedure: Video-Assisted Thoracoscopic	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urokinase urokinase infusion for 3 days	Drug: Urokinase Chest tube with intrapleural urokinase infusion for 3 days
Active Comparator: Thoracoscopic Video-Assisted Thoracoscopic	Procedure: Video-Assisted Thoracoscopic Video-Assisted Thoracoscopic decortication

Arm

Intervention/Treatment

Experimental: Urokinase

urokinase infusion for 3 days

Drug: Urokinase

Chest tube with intrapleural urokinase infusion for 3 days

Active Comparator: Thoracoscopic

Video-Assisted Thoracoscopic

Procedure: Video-Assisted Thoracoscopic

Video-Assisted Thoracoscopic decortication

Outcome Measures

Primary Outcome Measures

duration of the hospital stay after the treatment [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain
2	Hospital de Donostia	San Sebastián	Donostia	Spain	20014
3	University Hospital Vall d'Hebron	Barcelona		Spain	08035
4	Hospital Gregorio Marañón	Madrid		Spain
5	Hospital Infantil La Paz	Madrid		Spain
6	Hospital Universitario 12 de Octubre	Madrid		Spain