RecruitingNot ApplicableNCT06434324

Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion

A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of Empyema/Complicated Parapneumonic Effusion

Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Mar 29, 2025

Study Type

INTERVENTIONAL

Conditions

Pleural infection

Summary

The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Purulent pleural fluid versus pleural fluid analysis demonstrating pH <7.2, glucose <60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis
Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN

Exclusion Criteria9

Unwillingness to give informed consent
Patients with known bleeding diathesis
Platelet count <50,000 per μL
INR >2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline)
Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment
Incarcerated patients
Presence of ipsilateral bronchopleural fistula
Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection