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

Overview

About this study

The purpose of this study is to evaluate the efficacy of saline irrigation via thoracostomy tube in addition to intrapleural lytic therapy versus intrapleural lytic therapy alone in the management of proven or suspected pleural space infections. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/29/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dagny Anderson, M.D.

Contact us for the latest status

Contact information:

Brandon Clapp

(507) 284-2122

Clapp.Brandon@mayo.edu

More information

Publications

  • Empyemas require aggressive antimicrobial and surgical management. However, the specifics of antimicrobial therapy have not been studied in clinical trials. The present study examines management and outcomes among a cohort of patients with empyema cared for in a tertiary-care referral hospital over a decade. Read More on PubMed
  • Pleural infection is increasing in incidence. Despite optimal medical management, up to 30% of patients will die or require surgery. Case reports suggest that irrigation of the pleural space with saline may be beneficial.A randomised controlled pilot study in which saline pleural irrigation (three times per day for 3 days) plus best-practice management was compared with best-practice management alone was performed in patients with pleural infection requiring chest-tube drainage. The primary outcome was percentage change in computed tomography pleural fluid volume from day 0 to day 3. Secondary outcomes included surgical referral rate, hospital stay and adverse events.35 patients were randomised. Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those receiving standard care (median (interquartile range) 32.3% (19.6-43.7%) reduction versus 15.3% (-5.5-28%) reduction) (p<0.04). Significantly fewer patients in the irrigation group were referred for surgery (OR 7.1, 95% CI 1.23-41.0; p=0.03). There was no difference in length of hospital stay, fall in C-reactive protein, white cell count or procalcitonin or adverse events between the treatment groups, and no serious complications were documented.Saline irrigation improves pleural fluid drainage and reduces referrals for surgery in pleural infection. A large multicentre randomised controlled trial is now warranted to evaluate its effects further. Read More on PubMed
  • More than 30% of patients with pleural infection either die or require surgery. Drainage of infected fluid is key to successful treatment, but intrapleural fibrinolytic therapy did not improve outcomes in an earlier, large, randomized trial. Read More on PubMed

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