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Completed

NCT Number: NCT00798278

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

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).

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Key information

Conditions

Empyema Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Suppuration

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Vall d'Hebron, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urokinase

Drug

Chest tube with intrapleural urokinase infusion for 3 days

Video-Assisted Thoracoscopic

Procedure

Video-Assisted Thoracoscopic decortication

Primary outcomes

  1. duration of the hospital stay after the treatment

    Time frame: 3 months

Secondary outcomes

  1. complications of the treatment and complications of the disease

    Time frame: 3 months

  2. total duration of the hospital stay

    Time frame: 3 months

  3. number of days carrying the chest drain

    Time frame: 3 months

  4. duration of the fever once the empyema has been drained

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Spanish Society of Pediatric Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2008
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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