Saline Flush for Empyema

(RELIEF Trial)

Recruiting at 5 trial locations

Overseen By Jennifer Duke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Surgical tubes, Informed consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 3 months

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether flushing a chest drain with saline (a saltwater solution) helps keep it clear for people with empyema, a lung infection with pus build-up. Researchers aim to determine if regular saline flushes can shorten hospital stays and improve chest health compared to flushing only when the tube is blocked. Participants are divided into two groups: one receives regular flushes every 6 hours, while the other receives flushes only when needed. The trial seeks participants with a pleural infection requiring a chest tube as part of their hospital care. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this saline flush technique is safe for patients with empyema?

Research has shown that saline flushes are generally safe. Previous studies demonstrated that using saline to rinse reduced the amount of infected fluid in the chest without major safety issues. Some individuals might notice a change in taste or smell when using prefilled syringes, but these effects are not harmful. Overall, saline flushes are well-tolerated, with no strong evidence of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using saline flushes for treating empyema because this approach is simple yet potentially effective. Unlike traditional methods that often rely on antibiotics and surgery to drain infected fluid, saline flushes aim to keep chest tubes clear without the need for constant intervention. This method could reduce complications and improve patient comfort by maintaining drainage with minimal disruption. Additionally, if patients are undergoing medication treatments directly in the chest, the saline flush can be seamlessly integrated with these therapies, offering a cohesive and streamlined approach to care.

What evidence suggests that saline flush is effective for empyema?

Research has shown that saline flushes can help clear infections in the pleural space, the area between the lungs and the chest wall. In this trial, participants in the Saline Intervention Arm will receive regular saline flushes. Previous studies have demonstrated a 32.3% reduction in fluid buildup with saline flushes, compared to just 15.3% in those who did not receive them. Another report showed that saline flushes successfully treated thoracic empyema, a type of lung infection. These findings suggest that saline flushes might effectively reduce infection and speed up recovery for conditions like empyema. ^{1 2 3 5 6}

Who Is on the Research Team?

Jennifer D Duke, MD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.

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

Exclusion Criteria

Patients who have surgical tubes that can't accommodate a three-way stopcock

Inability to provide informed consent

Inability to undergo a chest X-ray

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive regular saline flushes into their chest drain every 6 hours or as needed to maintain patency

up to 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including additional surgical procedures and time to chest tube removal

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Saline Flush

Trial Overview 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.

How Is the Trial Designed?

Group I: Saline Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 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 Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study involving 50 pediatric patients aged 6 to 18 years, 72% reported taste and odor disturbances after flushing IV lines with prefilled syringes of normal saline, compared to only 4% with freshly prepared saline, indicating a significant difference (p < 0.001).

The findings suggest that the plastic materials in commercially available prefilled syringes may leach volatile substances into the saline, causing these disturbances, highlighting the importance of preparation methods in minimizing patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taste and Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled or Freshly Prepared Syringes: Randomized Single-Blind Study. Mancini, D., Vaillancourt, R., Pouliot, A., et al.[2019]

A randomized clinical trial involving 20 healthy volunteers found that a buffered preservative-free acidified solution for nasal spray was safe and well tolerated, with no significant differences in sinonasal symptoms compared to a standard preservative-containing spray.

Both nasal spray solutions maintained sterility without any microorganism growth, suggesting that the preservative-free solution could be a viable alternative to traditional chemical preservatives in preventing microbial contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a preservative-free acidified saline nasal spray: a randomized, double-blind, placebo-controlled, crossover clinical trial. Ryan, WR., Hwang, PH.[2015]

In a study of 30 patients undergoing endoscopic endonasal sinus surgery, those treated with Ems brine inhalations showed significantly better recovery outcomes, including reduced swelling and inflammation, compared to those receiving saline solution.

The use of Ems brine inhalations resulted in improved nasal flow and less crusting and bleeding, indicating its potential efficacy as a postoperative treatment in enhancing recovery after sinus surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative inhalation treatment after paranasal sinus interventions. A placebo-controlled, double-blind and randomized study]. Michel, O., Charon, J.[2015]

In a study involving 40 adult patients with chronic paranasal sinus disease, both Ems salt solution and sodium chloride solution were found to be effective in improving symptoms, with significant improvements noted in subjective complaints and endonasal examinations.

There was no significant difference in effectiveness between the two solutions, indicating that both types of endonasal irrigations can be used interchangeably for treating chronic sinusitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of irrigation of the nose with isotonic salt solution on adult patients with chronic paranasal sinus disease. Bachmann, G., Hommel, G., Michel, O.[2019]

In a study of 127 adults with chronic nasal and sinus symptoms, nasal irrigations using large volumes and low positive pressure significantly improved quality of life, as shown by lower SNOT-20 scores compared to saline sprays over an 8-week period.

At the 8-week mark, only 40% of patients using the irrigation method reported frequent symptoms, compared to 61% in the spray group, indicating that the irrigation method was more effective in reducing symptom frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Pynnonen, MA., Mukerji, SS., Kim, HM., et al.[2015]

In a study of 9 patients with post-surgical thoracic empyema, antibiotics amoxicillin and vancomycin showed good diffusion into the pleural cavity, with pleural concentrations often higher than those in the plasma.

The treatment was effective, with 8 out of 9 patients experiencing a cure of their pleural infection, indicating that these antibiotics can be effective in managing post-surgical empyema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pleural diffusion of amoxicillin 1 and vancomycin in patients treated for post-surgical empyema]. Stern, JB., Péan, Y., Girard, P., et al.[2019]

In a study of 62 patients with complicated parapneumonic effusions or empyemas, adding manual pleural saline flushing to urokinase treatment significantly reduced the need for multiple doses of fibrinolytics, with only 15% requiring more than one dose compared to 44% in the urokinase-only group.

Patients receiving saline flushing also experienced shorter chest tube duration (2 days vs. 5 days) and reduced hospital stays (6 days vs. 8 days), with no reported adverse events from the saline therapy, indicating it is a safe and effective adjunct treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual Intrapleural Saline Flushing Plus Urokinase: A Potentially Useful Therapy for Complicated Parapneumonic Effusions and Empyemas. Porcel, JM., Valencia, H., Bielsa, S.[2019]

In a 2-month study involving medical and surgical floor patients, saline flushes were found to cause significantly less phlebitis compared to heparin flushes (p < 0.025).

There was no difference in catheter loss of patency between saline and heparin, but when considering both phlebitis and loss of patency, saline showed a statistically significant advantage (p < 0.05), leading to a recommendation against using heparin in flushing procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heparin versus saline flushing solutions in a small community hospital. Barrett, PJ., Lester, RL.[2022]

Using a saline flush without proper visualization can increase the risk of administering medication through the wrong route, which can be dangerous.

This practice highlights the importance of ensuring correct administration techniques to prevent potential medical errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Saline Flush "Site Unseen" Could Lead to a Wrong-Route Error. Grissinger, M.[2020]

Heparin flush solutions are more effective than normal saline for maintaining the patency of arterial lines over longer durations (beyond 48 hours), based on a review of ten studies involving adult subjects.

There were no reported adverse effects associated with heparin flush, and higher doses in continuous infusion showed better patency rates without causing heparin-induced thrombocytopenia (HIT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of normal saline in the maintenance of the arterial lines in comparison to heparin flush: a comprehensive review of the literature. Kordzadeh, A., Austin, T., Panayiotopoulos, Y.[2017]

A survey of 134 patients who underwent endonasal sinus surgery found that 95% found nasal cleaning with saline solutions easy, and 84.7% found it pleasant, indicating high acceptance of this postoperative treatment method.

There was no significant difference in effectiveness or patient preference between using Ems brine and saline solution, or between using a nasal douche and sniffing from the hand, suggesting flexibility in how patients can perform nasal irrigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and tolerance of nasal irrigation following paranasal sinus surgery]. Keerl, R., Weber, R., Müller, C., et al.[2015]

In a study of 42 patients with pleural empyema, serial thoracocentesis combined with saline irrigation was highly effective for treating empyema resulting from pneumonia, achieving an 86% success rate without needing more invasive procedures.

The treatment was less effective for empyema caused by other factors, with only a 69% success rate and a significant crossover to more invasive therapies, indicating that different approaches may be necessary for non-pneumonic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of thoracic empyema. Simmers, TA., Jie, C., Sie, B.[2014]

In a randomized trial of 53 patients with pleural empyema, the use of intrapleural streptokinase alongside chest tube drainage significantly improved clinical treatment success after 7 days (82% vs. 48% for saline, p = 0.01).

Patients receiving streptokinase also had a lower need for surgical intervention (9% vs. 45% for saline, p = 0.02), indicating that streptokinase can be an effective adjunctive treatment in managing pleural empyema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapleural streptokinase for empyema and complicated parapneumonic effusions. Diacon, AH., Theron, J., Schuurmans, MM., et al.[2022]

In a study of 49 patients with parapneumonic empyema, treatment with intrapleural urokinase resulted in a significantly shorter duration of fever (7 days) compared to normal saline (13 days), indicating better efficacy.

Patients receiving urokinase also experienced greater fluid drainage (1.8 liters) and shorter hospital stays (14 days) compared to those treated with saline (0.8 liters and 21 days), suggesting that urokinase improves treatment outcomes and reduces the need for more invasive procedures like decortication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapleural urokinase in the management of parapneumonic empyema: a randomised controlled trial. Tuncozgur, B., Ustunsoy, H., Sivrikoz, MC., et al.[2008]

Citations

1. publications.ersnet.org publications.ersnet.org/content/erj/46/2/456

Pleural irrigation trial (PIT): a randomised controlled trial of ... Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those receiving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9629991/

Medical management of pleural infection: Why not saline ... Thus, saline irrigation resulted in a 32.3% reduction in computed tomography‐assessed pleural collection volume, compared to 15.3% receiving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316260/

The novel treatment of intrapleural saline irrigation with ... We report two cases of thoracic empyema that were successfully treated with intrapleural saline irrigation and intrapleural tyloxapol apart from parenteral ...

4. withpower.com withpower.com/trial/phase-empyema-5-2024-47310

Saline Flush for Empyema (RELIEF Trial) In a study of 30 patients undergoing endoscopic endonasal sinus surgery, those treated with Ems brine inhalations showed significantly better recovery outcomes, ...

5. ctv.veeva.com ctv.veeva.com/study/pleural-irrigation-with-normal-saline-versus-intrapleural-fibrinolytic

Pleural Irrigation With Normal Saline Versus Intrapleural ... Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/20/NCT06314620/Prot_SAP_ICF_000.pdf

SAFETY AND EFFICACY OF 8 HOURLY NORMAL SALINE ... However, there is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal ...