RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating the Efficacy and Safety of Saline Irrigation As an Add-On Therapy for Retained Pleural Infections (LYTICS +)

Quick Facts

Study Start:2025-03-10
Study Completion:2025-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06713382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years.
  2. * Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
  3. * pH ≤ 7.2.
  4. * Glucose \< 40 mg/dL.
  5. * LDH \> 1000 IU/L.
  6. * Presence of bacterial or fungal organisms on Gram stain or culture.
  7. * Chest tube placement with less than 200 mL drainage in 24 hours.
  8. * Indication for IPFT treatment based on treating physician's criteria.
  9. * Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).
  1. * Inability to provide informed consent.
  2. * Pregnant patients.
  3. * Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
  4. * Complicated sympathetic effusion.
  5. * Hepatic hydrothorax.

Contacts and Locations

Study Contact

Adnan Majid, MD
CONTACT
6179016430
amajid@bidmc.harvard.edu
Maria C Lopez, MD
CONTACT
7869678448
mlopezgi@bidmc.harvard.edu

Principal Investigator

Adnan Majid, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Adnan Majid, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2025-12-20

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2025-12-20

Terms related to this study

Keywords Provided by Researchers

  • Pleural Effusion
  • Thoracentesis
  • Tissue Plasminogen Activator
  • DNase
  • Therapeutic Irrigation

Additional Relevant MeSH Terms

  • Pleural Effusion Associated with Pulmonary Infection
  • Pleural Effusion Disorder
  • Pleural Effusions