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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

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I am older than 18 years.

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I have a severe lung infection requiring a chest tube as part of my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

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.

0 / 2Eligibility criteria met