Status:
COMPLETED
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
Lead Sponsor:
National University of Malaysia
Conditions:
Loculated Empyema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in...
Detailed Description
The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) ...
Eligibility Criteria
Inclusion
- adult patient with age more than 17 year old
- evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 mL after 24 hours of insertion of chest drain
- clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or white-cell count
- complex pleural effusion proven by ultrasound
- pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (LDH) \> 1000 U/L, pH \< 7.2 and/or glucose level \< 3.3mmol/L
Exclusion
- known allergy to pulmozyme or alteplase
- acute stroke, active bleeding diathesis
- major surgery in past 5 days
- previous pneumonectomy on the infected side
- bronchopleural fistula
- pregnancy
- coagulopathy (INR \> 2, APTT \>100, platelet count \< 50,000 cells)
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04915586
Start Date
December 30 2019
End Date
December 31 2020
Last Update
June 7 2021
Active Locations (1)
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1
University Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000