Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial, called LYTICS +, is studying a new treatment approach for patients with persistent pleural infections, which occur when fluid builds up in the space around the lungs due to infection. The trial aims to evaluate whether adding saline irrigation—a method of flushing the area with saltwater—can improve treatment outcomes when used alongside standard therapy known as intrapleural fibrinolytic therapy (IPFT). IPFT is often used when infections aren't responding well to antibiotics and tube drainage. This research is important because while IPFT is effective, it may not be suitable for everyone, especially those at high risk of bleeding.

To participate in this trial, individuals must be 18 years or older and have specific signs of infection in their pleural fluid, such as a low pH or certain bacteria present. Participants will receive either the saline irrigation combined with IPFT or IPFT alone, and researchers will assess how well the treatment works and if it is safe and comfortable for patients. Key factors being measured include how much fluid is drained, how long patients stay in the hospital, and the need for any additional surgeries. This trial is currently recruiting participants and aims to provide valuable insights into improving care for patients facing these challenging infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• * Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
• • pH ≤ 7.2.
• • Glucose \< 40 mg/dL.
• • LDH \> 1000 IU/L.
• • Presence of bacterial or fungal organisms on Gram stain or culture.
• • Chest tube placement with less than 200 mL drainage in 24 hours.
• • Indication for IPFT treatment based on treating physician's criteria.
• • Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).
• Exclusion Criteria:
• • Inability to provide informed consent.
• • Pregnant patients.
• • Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
• • Complicated sympathetic effusion.
• • Hepatic hydrothorax.