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

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

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.

Study Overview

• Status: Unknown
• Conditions: Empyema, Pleural
• Intervention / Treatment: Drug: insertion of a chest drain with urokinase instillation; Procedure: primary video-assisted thorascopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • Queen Fabiola University Children Hospital
    • Contact: Nicolas Lefevre, MD; Email: nicolas.lefevre@huderf.be
    • Principal Investigator: Nicolas Lefevre, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: VATS; primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms	Procedure: primary video-assisted thorascopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
length of hospital stay	Hospital departure with an expected average time of two weeks to one month
Duration of oxygen therapy	up to the end of patient hospitalisation with an expected average time of 48 hours to five days
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
Duration of fever > 38.5°C	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	Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
Patient discomfort	Up to chest drain removal with an average expected time of 48 hours up to seven days

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Suppuration; Pleural Effusion; Empyema; Empyema, Pleural
• Other Study ID Numbers: P2013/PE1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No