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

Empyema, Pleural Clinical Trial

— UROVATS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02165891
• Other study ID #: P2013/PE1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural
• Pleural Effusion

Intervention

Drug:
• insertion of a chest drain with urokinase instillation
Other interventions except drainage procedure are the same in both arms

Procedure:
• primary video-assisted thorascopic surgery

Locations

Country	Name	City	State
Belgium	Queen Fabiola University Children Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of drainage		end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
Secondary	length of hospital stay		Hospital departure with an expected average time of two weeks to one month
Secondary	Duration of oxygen therapy		up to the end of patient hospitalisation with an expected average time of 48 hours to five days
Secondary	duration of intravenous antibiotic therapy		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
Secondary	Duration of fever > 38.5°C		Up to fever resolution, with an average expected time of five days to 14 days
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
Secondary	Patient discomfort		Up to chest drain removal with an average expected time of 48 hours up to seven days