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Trial record 45 of 64 for:    Recruiting, Not yet recruiting, Available Studies | "Pleural Effusion"

Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children (UROVATS)

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ClinicalTrials.gov Identifier: NCT02165891
Recruitment Status : Recruiting
First Posted : June 18, 2014
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

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.


Condition or disease Intervention/treatment Phase
Empyema, Pleural Drug: insertion of a chest drain with urokinase instillation Procedure: primary video-assisted thorascopic surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Treatment of Parapneumonic Pleural Effusion in Children
Study Start Date : February 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase

Arm Intervention/treatment
Urokinase
insertion of a chest drain with urokinase instillation
Drug: insertion of a chest drain with urokinase instillation
Other interventions except drainage procedure are the same in both arms

VATS
primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms
Procedure: primary video-assisted thorascopic surgery



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. length of hospital stay [ Time Frame: Hospital departure with an expected average time of two weeks to one month ]
  2. Duration of oxygen therapy [ Time Frame: up to the end of patient hospitalisation with an expected average time of 48 hours to five days ]
  3. 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 ]
  4. Duration of fever > 38.5°C [ Time Frame: Up to fever resolution, with an average expected time of five days to 14 days ]
  5. 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 ]
  6. Patient discomfort [ Time Frame: Up to chest drain removal with an average expected time of 48 hours up to seven days ]


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients under the age of 17
  • pleural fluid depth of at least 15mm, confirmed by ultrasound
  • at least one of the following severity criteria :

    1. fever continuing 48h after starting correct antibiotherapy
    2. respiratory distress
    3. mediastinal displacement on the chest X-ray

Exclusion Criteria:

  • previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
  • congenital pulmonary disorders with lung function impairment
  • chronic pulmonary disease associated with lung function impairment
  • hemodynamic instability
  • congenital immunodeficiency disease
  • secondary immune deficiency induced
  • hemostasis disorder (contraindication of thrombolytic therapy)
  • pregnancy or breastfeeding patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165891


Locations
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Belgium
Queen Fabiola University Children Hospital Recruiting
Brussels, Belgium, 1020
Contact: Nicolas Lefevre, MD       nicolas.lefevre@huderf.be   
Principal Investigator: Nicolas Lefevre, MD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital

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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT02165891     History of Changes
Other Study ID Numbers: P2013/PE1
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Pleural Effusion
Empyema
Empyema, Pleural
Pleural Diseases
Respiratory Tract Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections