Comparing saline irrigation and fibrinolytic treatment for pleural infections

A Randomised Open-Label Controlled Trial of Pleural Irrigation With Normal Saline Versus Intrapleural Tissue Plasminogen Activator and DNase (Fibrinolytic Therapy) in Pleural Infection.

This study is testing if a new treatment using a medication called alteplase can help people with serious lung infections drain fluid better than the usual saline washout method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National University of Malaysia (Academic / other)
• Locations: 1 site (Kuala Lumpur, Wilayah Persekutuan)
• Trial ID: NCT05903417 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intrapleural fibrinolytic therapy using alteplase and DNase compared to saline irrigation in treating pleural infections, specifically complex parapneumonic effusions and empyema. The study aims to measure the volume of pleural effusion drainage after 48 hours, alongside secondary objectives such as changes in inflammatory markers, length of hospital stay, and the need for surgical intervention. Participants will be randomly assigned to either treatment group, and outcomes will be assessed over a 30-day period. The trial seeks to determine if fibrinolytic therapy provides superior results in managing pleural infections.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with complex parapneumonic effusions or empyema and poor pleural fluid drainage.

Not a fit: Patients who refuse to participate or have known allergies to t-PA or DNase will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with pleural infections, potentially reducing the need for surgical interventions.

How similar studies have performed: While the efficacy of saline irrigation is not well-established, the use of fibrinolytic therapy has shown promise in similar studies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Adult patient with aged ≥ 18 years old 2. Patients with pleural infection (complex parapneumonic effusion or empyema) with poor pleural fluid drainage of ≤ 150 ml after 24H of insertion of chest drain 3. Clinical features consistent with pleural infection ; fulfilling ≥ 2 of the following characteristics : i) Clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or total white blood count (TWBC) ii) Complex pleural effusion proven by thoracic ultrasound is defined as presence of fibrin strands or septations within pleural cavity iii) Pleural fluid that fulfil at least one of the characteristic :

* frank pus,
* exudative type of pleural effusion (according to light's criteria)
* gram stain or culture positive
* lactate dehydrogenase (LDH) \> 900U/L
* Acidic with ph \< 7.2
* glucose level \< 3.3 mmol/L

Exclusion Criteria:

1. Refusal to participate
2. Known allergy to t-PA or DNase
3. Acute stroke
4. Significant bleeding diathesis/ active gastrointestinal bleed
5. Major surgery in the previous 5 days
6. Previous pneumonectomy on the infected side
7. Bronchopleural fistula
8. Pregnancy
9. Coagulapathy (INR \> 2, APTT \> 100)
10. Platelet count \< 50000 cells

Where this trial is running

Kuala Lumpur, Wilayah Persekutuan

• National University of Malaysia — Kuala Lumpur, Wilayah Persekutuan, Malaysia (Recruiting)

Study contacts

• Principal investigator: Mohamed Faisal Abdul Hamid, MBBS (IIUM) — National University of Malaysia
• Study coordinator: Mohamed Faisal Abdul Hamid, MBBS(IIUM)

Conditions Pleural Infection