Recruiting

Saline Irrigation

Sponsor:

Mayo Clinic

Code:

NCT06434324

Conditions

Pleural Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Saline Irrigation

Study Details

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

Study ID

NCT06434324

Start date

Mar 29, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Saline Irrigation Group

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

no intervention: Standard of Care Group

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

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

Primary outcome measure

  • Adequate pleural space evacuation [ Time Frame: Approximately 3 days ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Dagny Anderson, MD

507-284-3104anderson.dagny@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-30.