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Saline Irrigation for Empyema

N/A
Waitlist Available
Led By Dagny Anderson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN
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
Must not have
Presence of ipsilateral bronchopleural fistula
Patients with known bleeding diathesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 14 days
Awards & highlights

Summary

This trial aims to determine if adding saline irrigation through a chest tube can help improve the treatment of people with a pleural space infection.

Who is the study for?
This trial is for individuals suspected or confirmed to have a pleural space infection, which includes conditions like empyema or complicated parapneumonic effusion.
What is being tested?
The study aims to determine if adding saline irrigation through a chest tube provides any benefits over the standard treatment for pleural space infections.
What are the potential side effects?
Potential side effects may include discomfort at the chest tube site, risk of additional infection from the procedure, and possible respiratory complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am starting treatment for fluid in my chest at Mayo Clinic in Rochester, MN.
Select...
My pleural fluid test shows infection or very low pH and glucose levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a connection between my lung and chest wall.
Select...
I have a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adequate pleural space evacuation
Secondary outcome measures
Need for additional interventions
Number of adverse events
Number of hospital days
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Saline Irrigation GroupExperimental Treatment1 Intervention
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
Group II: Standard of Care GroupActive Control1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline Irrigation
2011
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,346 Total Patients Enrolled
Dagny Anderson, MDPrincipal InvestigatorMayo Clinic
~40 spots leftby Jan 2026
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