Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

NCT06427538 | Recruiting

• 1 other identifier: 231367
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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

Keywords

empyema; pleural infection; chest tube; saline flush

Outcome Measures

Primary Outcomes (1)

• Time to chest tube removal

  The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal

  up to 3 months

Secondary Outcomes (4)

• Length of hospitalization

  up to 365 days

• Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal

  through study completion, an average of 3 months

• Additional surgical procedures for the management of pleural space infection

  an average of 3 months

• Complications

  through study completion, an average of 3 months

Study Arms (2)

Saline Intervention Arm

EXPERIMENTAL

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.

Other: Saline Flush

No Intervention Arm

NO INTERVENTION

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 OTHER

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

Saline Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (5)

Henry Ford

Sterling Heights, Michigan, 48310, United States

RECRUITING

Creighton University

Omaha, Nebraska, 68124, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Related Publications (1)

• Boyle TK, Duke JD, Yermakhanova G, Paez R, Bridwell G, Ratwani AP, Leonard KM, Chen H, Harrell FE Jr, Lentz RJ, Maldonado F, Rahman NM, Shojaee S. Chest drain REgular FLushing in ComplIcated parapneumonic EFfusions and empyemas: Study protocol for the RELIEF randomized controlled trial. PLoS One. 2026 Mar 5;21(3):e0331725. doi: 10.1371/journal.pone.0331725. eCollection 2026.

  PMID: 41785244 DERIVED

MeSH Terms

Conditions

Empyema, Pleural; Empyema

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer D Duke, MD

  Vanderbilt University

  STUDY DIRECTOR

Central Study Contacts

Samira Shojaee, MD, MPH

CONTACT

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

Jennifer Duke, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 24, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)