Empyema, PleuralRELIEFNCT06427538
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
A study testing Saline Flush in people with Empyema, Pleural and Pleural Infection, run by Vanderbilt University Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empyema, Pleural, Pleural Infection
- What is being tested?
- Saline Flush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Jun 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
- Recruiting
Mount Sinai
New York, New York, 10029
Udit S Chaddha, 212-241-5656, udit.chaddha@mssm.edu
- Recruiting
Creighton University
Omaha, Nebraska, 68124
Zachary S DePew, MD, 402-717-9600, zachary.depew@commonspirit.org
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Danai Khemasuwan, 804-828-6396, Danai.Khemasuwan@vcuhealth.org
- Recruiting
Henry Ford
Sterling Heights, Michigan, 48310
Labib Debiane, MD, 800-436-7936, ldebian1@hfhs.org
About this study
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.
Read the detailed description
There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of <16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.
- Conditions
- Empyema, Pleural, Pleural Infection
- Being tested
- Saline Flush
- Keywords
- empyema, pleural infection, chest tube, saline flush
- Medical subject headings
- Empyema, Pleural, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline FlushOther
sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 months
Secondary outcomes (4)
Length of hospitalization
Measured: 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
Measured: through study completion, an average of 3 months
Additional surgical procedures for the management of pleural space infection
number of additional procedures through study completion
Measured: an average of 3 months
Complications
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start21 Jun 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Shojaee, Vanderbilt University Medical Center
- Investigators
- Jennifer D Duke, MD, Study director, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427538
- Sponsor's protocol ID
- 231367
- Acronym
- RELIEF
- Status last verified
- Feb 2026
- First submitted
- 10 May 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be shared with other researchers
Publications
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.
PubMed 41785244
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
- ClinicalTrials.gov ID
- NCT06427538
- Acronym / sponsor ID
- RELIEF / 231367
- Conditions
- Empyema, Pleural, Pleural Infection
- Keywords
- empyema, pleural infection, chest tube, saline flush
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of <16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Intervention Arm | Experimental | Other: Saline FlushPatient 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Flushsterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours | Other | Saline Intervention Arm |
Primary outcome
Time to chest tube removal
Time frame: up to 3 months
The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal
4 secondary outcomes
Length of hospitalization
Time frame: 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
Time frame: through study completion, an average of 3 months
Additional surgical procedures for the management of pleural space infection
Time frame: an average of 3 months
Complications
Time frame: through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Derived from this study: PubMed 41785244Boyle 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.
- Individual participant dataSharing planned: No. Deidentified data will be shared with other researchers
Related trials for Empyema, Pleural
RecruitingPhase 4
VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.
Empyema, Pleural, Pleural Infections
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruiting
Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
Pleural Empyema
RecruitingPhase 4
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
Pleural Infection Bacterial, Pleural Infections
Not yet recruitingPhase 4
Flush, Lyse, Operate
Complicated Parapneumonic Effusion, Empyema, Pleural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer D Duke, MD study director
Vanderbilt University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Flush in people with Empyema, Pleural and Pleural Infection, run by Vanderbilt University Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samira Shojaee, MD, MPH (615-322-2386, samira.shojaee@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to chest tube removal (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.