Loculated Empyema
Conditions
Keywords
Intrapleural fibrinolysis, pleural infection
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 patients with pleural infection.
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) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.
Interventions
DRUGIntra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Sponsors
National University of Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The radiologists were blinded to patient identity and intervention timing
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic improvement in pleural opacity on chest radiograph | Day 7 | measured in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in inflammatory markers C-Reactive Protein (CRP ) | Day 7 | reduction of inflammatory markers trend |
| White cell count | Day 7 | changes in inflammatory markers trend |
| length of hospitalisation | upto 30 days | days |
| pleural fluid volume drained | Day 7 | measured in mls |
| adverse events post therapy | Day 7 | pain, bleeding events, hemodynamic stability |
| mortality rate at day 30 post intervention | 30 days | days |
| the need of surgical referral | upto 30 days | if evidence of clinical deterioration post intrapleural therapy such as intrapleural haemorrhage or hypotension or less than 50% resolution of effusion on chest-xray post intrapleural therapy |
Countries
Malaysia
Outcome results
None listed