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

NCT06434324 | Recruiting

• 2 other identifiers: 23-013234HT9425-24-C-0010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Infection

Outcome Measures

Primary Outcomes (1)

• Adequate pleural space evacuation

  Number of intrapleural fibrinolytic doses to achieve adequate pleural space evacuation (defined as \<=2.5 cm separation between parietal and visceral pleural layers on bedside ultrasound or no more than small residual effusion on clinically-directed CT chest imaging).

  Approximately 3 days

Secondary Outcomes (5)

• Need for additional interventions

  Approximately 10 days

• Thoracostomy tube days

  Approximately 10 days

• Number of hospital days

  Approximately 14 days

• Pain tolerance of pleural space irrigation

  Approximately 3 days

• Number of adverse events

  Approximately 10 days

Study Arms (2)

Saline Irrigation Group

EXPERIMENTAL

Subjects will receive twice daily fibrinolytic therapy in addition to daily saline irrigation through their chest tube until the treating physician determines that the pleural space has been adequately evacuated

Procedure: Saline Irrigation

Standard of Care Group

NO INTERVENTION

Subjects will receive twice daily fibrinolytic therapy through their chest tube until the treating physician determines that the pleural space has been adequately evacuated

Interventions

Saline Irrigation PROCEDURE

250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis

Saline Irrigation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (5)

• Bedawi EO, Ricciardi S, Hassan M, Gooseman MR, Asciak R, Castro-Anon O, Armbruster K, Bonifazi M, Poole S, Harris EK, Elia S, Krenke R, Mariani A, Maskell NA, Polverino E, Porcel JM, Yarmus L, Belcher EP, Opitz I, Rahman NM. ERS/ESTS statement on the management of pleural infection in adults. Eur Respir J. 2023 Feb 2;61(2):2201062. doi: 10.1183/13993003.01062-2022. Print 2023 Feb.

  PMID: 36229045 BACKGROUND

• Birkenkamp K, O'Horo JC, Kashyap R, Kloesel B, Lahr BD, Daniels CE, Nichols FC 3rd, Baddour LM. Empyema management: A cohort study evaluating antimicrobial therapy. J Infect. 2016 May;72(5):537-43. doi: 10.1016/j.jinf.2016.02.009. Epub 2016 Mar 15.

  PMID: 26987740 BACKGROUND

• Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.

  PMID: 21830966 BACKGROUND

• Mismetti V, Froudarakis ME. Medical management of pleural infection: Why not saline intrapleural lavage? Clin Respir J. 2022 Nov;16(11):693-695. doi: 10.1111/crj.13548. Epub 2022 Sep 29. No abstract available.

  PMID: 36173249 BACKGROUND

• Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.

  PMID: 26022948 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Dagny Anderson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: March 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)