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

NCT02165891 | Unknown Phase 3

• 1 other identifier: P2013/PE1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Empyema, Pleural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Urokinase

OTHER

insertion of a chest drain with urokinase instillation

Drug: insertion of a chest drain with urokinase instillation

VATS

OTHER

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

Procedure: primary video-assisted thorascopic surgery

Interventions

insertion of a chest drain with urokinase instillation DRUG

Other interventions except drainage procedure are the same in both arms

Urokinase

primary video-assisted thorascopic surgery PROCEDURE

VATS

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients under the age of 17
• pleural fluid depth of at least 15mm, confirmed by ultrasound
• at least one of the following severity criteria :
• fever continuing 48h after starting correct antibiotherapy
• respiratory distress
• mediastinal displacement on the chest X-ray

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (1)

Queen Fabiola University Children Hospital

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Empyema, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: June 18, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

BE (1)