Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06713382

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

Led by Beth Israel Deaconess Medical Center · Updated on 2025-05-25

96

Participants Needed

1

Research Sites

88 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections. The specific aims of the study include: Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention. Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of purulent pleural fluid or pleural fluid analysis showing any of the following: pH 7.2 or less, glucose under 40 mg/dL, or LDH over 1000 IU/L
  • Presence of bacteria or fungi in pleural fluid by Gram stain or culture
  • Chest tube placed with less than 200 mL drainage in 24 hours
  • Physician has indicated treatment with intrapleural fibrinolytic therapy (IPFT)
  • Radiographic evidence of septations on chest ultrasound or loculations on low-dose chest CT
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Pregnant
  • Significant other health problems that could affect study results, such as terminal cancer
  • Complicated sympathetic effusion
  • Hepatic hydrothorax

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

A

Adnan Majid, MD

CONTACT

M

Maria C Lopez, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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