Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empy… (NCT06434324) | Clinical Trial Compass
RecruitingNot Applicable
Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion
United States60 participantsStarted 2025-03-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* 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 Criteria:
* 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