Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06427538

Conditions

Empyema, Pleural

Pleural Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Saline Flush

Study Details

Brief summary:

Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.

Conditions

Empyema, Pleural

Pleural Infection

Study ID

NCT06427538

Start date

Jun 21, 2024

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Age > 18 years old.

Exclusion Criteria:

  • Patients who have surgical tubes that can't accommodate a three-way stopcock.
  • Study subject has any disease or condition that interferes with the safe completion of the study.
  • Inability to provide informed consent.
  • Inability to undergo a chest X-ray.
  • If the managing clinician believes the chest tube will be placed for less than 24 hours.
  • Patients with an indwelling pleural catheter (IPC)

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Saline Intervention Arm

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.

no intervention: No Intervention Arm

Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.

Interventions

Saline Flush

sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours

Primary outcome measure

  • Time to chest tube removal [ Time Frame: up to 3 months ]

Central Contacts and Locations

Central contacts

Samira Shojaee, MD, MPH

615-322-2386samira.shojaee@vumc.org

Jennifer Duke, MD

615-322-2386jennifer.duke@vumc.org

Locations

Henry Ford

Recruiting

Sterling Heights, Michigan, United States, 48310

Contacts

Labib Debiane, MD

800-436-7936ldebian1@hfhs.org

Creighton University

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

Zachary S DePew, MD

402-717-9600zachary.depew@commonspirit.org

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Udit S Chaddha

212-241-5656udit.chaddha@mssm.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Danai Khemasuwan

804-828-6396Danai.Khemasuwan@vcuhealth.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • empyema
  • pleural infection
  • chest tube
  • saline flush

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-02-20.