## Protocol Section
### Identification Module
**NCT ID:** NCT06427538

**Acronym:** RELIEF

**Brief Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

**Official Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

#### Organization Study ID Info
**ID:** 231367
#### Organization
**Class:** OTHER
**Full Name:** Vanderbilt University Medical Center
### Status Module
#### Completion Date
**Date:** 2025-10-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Vanderbilt University Medical Center

#### Responsible Party

**Investigator Affiliation:** Vanderbilt University Medical Center

**Investigator Full Name:** Samira Shojaee

**Investigator Title:** Associate Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Empyema, Pleural

- Pleural Infection

**Keywords:**

- empyema

- pleural infection

- chest tube

- saline flush

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Saline Flush

**Label:** Saline Intervention Arm

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** No Intervention Arm

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Saline Intervention Arm

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

**Name:** Saline Flush

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Time to chest tube removal

**Time Frame:** up to 3 months

#### Secondary Outcomes

**Measure:** Length of hospitalization

**Time Frame:** up to 365 days

**Measure:** 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

**Description:** number of additional procedures through study completion

**Measure:** Additional surgical procedures for the management of pleural space infection

**Time Frame:** an average of 3 months

**Measure:** Complications

**Time Frame:** through study completion, an average of 3 months

### Eligibility Module

**Eligibility Criteria:** 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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** samira.shojaee@vumc.org

**Name:** Samira Shojaee, MD, MPH

**Phone:** 615-322-2386

**Role:** CONTACT

**Contact 2:**

**Email:** jennifer.duke@vumc.org

**Name:** Jennifer Duke, MD

**Phone:** 615-322-2386

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37203

#### Overall Officials

**Official 1:**

**Affiliation:** Vanderbilt University

**Name:** Jennifer D Duke, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Deidentified data will be shared with other researchers

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000012877

- Term: Skin Manifestations

- ID: D000013492

- Term: Suppuration

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000010995

- Term: Pleural Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7819

- Name: Empyema

- Relevance: HIGH

- As Found: Empyema

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19086

- Name: Empyema, Pleural

- Relevance: HIGH

- As Found: Empyema, Pleural

- ID: M8610

- Name: Flushing

- Relevance: HIGH

- As Found: Flushing

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M16273

- Name: Suppuration

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13885

- Name: Pleural Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004653

- Term: Empyema

- ID: D000016724

- Term: Empyema, Pleural

- ID: D000005483

- Term: Flushing

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13848

- Name: Plasminogen

- Relevance: LOW

- As Found: Unknown

- ID: M13849

- Name: Tissue Plasminogen Activator

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
