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Saline Flush for Empyema (RELIEF Trial)

N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old.
Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if regularly flushing chest drains with saline solution can help clear blockages and improve patient outcomes, such as reducing the time the chest tube is needed and the overall hospital stay.

Who is the study for?
This trial is for patients with infections in the space around their lungs, requiring chest drains. Participants must need antibiotics and a chest drain due to infected fluid. The study excludes individuals if specific criteria that could interfere with the trial's process or outcomes are met.
What is being tested?
The study tests whether flushing the chest drain with saline solution helps keep it clear, potentially reducing how long it stays in and overall hospital stay. It also looks at improvements in lung imaging and if fewer follow-up procedures are needed.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort during flushing, infection risk from introducing saline into the body, or possible complications related to maintaining a chest drain longer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
I have a severe lung infection requiring a chest tube as part of my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to chest tube removal
Secondary study objectives
Additional surgical procedures for the management of pleural space infection

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Saline Intervention ArmExperimental Treatment1 Intervention
Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush.
Group II: No Intervention ArmActive Control1 Intervention
Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
895 Previous Clinical Trials
934,683 Total Patients Enrolled
Jennifer D Duke, MDStudy DirectorVanderbilt University
~64 spots leftby Jun 2025
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