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

Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00798278
Enrollment
200
Registered
2008-11-26
Start date
2008-07-31
Completion date
2010-09-30
Last updated
2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empyema, Pneumonia

Keywords

Empyema, Urokinase, Thoracoscopic, Childhood

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).

Interventions

Chest tube with intrapleural urokinase infusion for 3 days

PROCEDUREVideo-Assisted Thoracoscopic

Video-Assisted Thoracoscopic decortication

Sponsors

Spanish Society of Pediatric Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
duration of the hospital stay after the treatment3 months

Secondary

MeasureTime frame
complications of the treatment and complications of the disease3 months
total duration of the hospital stay3 months
number of days carrying the chest drain3 months
duration of the fever once the empyema has been drained3 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026