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

Queen Fabiola Children's University Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Empyema, Pleural

Interventions

insertion of a chest drain with urokinase instillationDRUG

Other interventions except drainage procedure are the same in both arms

primary video-assisted thorascopic surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 1 YearMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Fabiola University Children Hospital

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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