Clinical Trial: Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drainage by Percutaneous Drain Associated With Urokinase in the Treatmen

Brief Summary:

Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.

The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.


Detailed Summary:
Sponsor: Queen Fabiola Children's University Hospital

Current Primary Outcome: duration of drainage [ Time Frame: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • length of hospital stay [ Time Frame: Hospital departure with an expected average time of two weeks to one month ]
  • Duration of oxygen therapy [ Time Frame: up to the end of patient hospitalisation with an expected average time of 48 hours to five days ]
  • duration of intravenous antibiotic therapy [ Time Frame: up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month ]
  • Duration of fever > 38.5°C [ Time Frame: Up to fever resolution, with an average expected time of five days to 14 days ]
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to the end of the hospitalisation, until three months corresponding to the end of follow up period ]
  • Patient discomfort [ Time Frame: Up to chest drain removal with an average expected time of 48 hours up to seven days ]


Original Secondary Outcome: Same as current

Information By: Queen Fabiola Children's University Hospital

Dates:
Date Received: February 26, 2014
Date Started: February 2015
Date Completion:
Last Updated: October 20, 2015
Last Verified: October 2015