Saline Flush for Empyema
(RELIEF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Disqualifiers: Surgical tubes, Informed consent, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Saline Flush for empyema?
Research shows that using saline flushes in combination with other treatments like urokinase can be effective for managing empyema, a condition where pus collects in the space around the lungs. Saline flushes alone have been used in studies to help treat empyema, suggesting they may help in clearing the infection.
12345Is saline flush generally safe for humans?
Saline flushes are generally safe for humans, but some people may experience taste and odor disturbances when using prefilled syringes due to substances from the plastic. There are no major safety concerns reported in the studies reviewed.
678910How does saline flush treatment for empyema differ from other treatments?
Saline flush treatment for empyema is unique because it uses a simple saltwater solution to help clear the infection, which is different from more complex treatments that might involve antibiotics or surgical interventions. This approach is less invasive and focuses on using the body's natural processes to aid recovery.
911121314Eligibility Criteria
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
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Saline Intervention ArmExperimental Treatment1 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 ArmActive Control1 Intervention
Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
References
[Pleural diffusion of amoxicillin 1 and vancomycin in patients treated for post-surgical empyema]. [2019]Treatment of post surgical thoracic empyema consists of chest tube drainage, antibiotic administration, and in some cases surgical lavage of infected spaces. Data in human on the diffusion of antibiotics in pleural cavity after post surgical empyema are lacking.
Manual Intrapleural Saline Flushing Plus Urokinase: A Potentially Useful Therapy for Complicated Parapneumonic Effusions and Empyemas. [2019]We sought to evaluate the safety profile and effectiveness of manual pleural saline flushing, in addition to urokinase, for managing complicated parapneumonic effusions and empyemas.
Minimally invasive treatment of thoracic empyema. [2014]The present study was undertaken to assess the efficacy of serial thoracocentesis and saline irrigation for the treatment of pleural empyema, for post-pneumonia versus other causes.
Intrapleural streptokinase for empyema and complicated parapneumonic effusions. [2022]We conducted a single-center, randomized, placebo-controlled trial to determine whether streptokinase instillations adjunctive to chest tube drainage reduce the need for surgery and improve outcome in patients with pleural empyema. Fifty-three patients (frank pus aspirated, 81%; microbiological agent cultured, 62%; mean effusion pH, 6.6 +/- 0.4) received antibiotic treatment, chest tube drainage, and once-daily pleural rinses with either normal saline or normal saline with streptokinase (250,000 IU). Nine patients were excluded for various reasons before pleural rinses were started. Streptokinase (n = 22) was instilled over 4.5 +/- 2 days and saline (n = 22) was instilled over 3 +/- 1.3 days. One patient in each group died during treatment. Clinical treatment success and need for referral to surgery were the main outcome measures. No difference was observed after 3 days. After 7 days, streptokinase-treated patients had a higher clinical success rate (82 vs. 48%, p = 0.01) and fewer referrals for surgery (45 vs. 9%, p = 0.02). No significant radiologic or functional differences were observed between groups during follow-up over 6 months. We conclude that intrapleural streptokinase adjunctive to chest tube drainage reduces the need for surgery and improves the clinical treatment success in patients with pleural empyema.
Intrapleural urokinase in the management of parapneumonic empyema: a randomised controlled trial. [2008]We compared the effectiveness of intrapleural urokinase versus normal saline via a thoracostomy tube in the treatment of parapneumonic empyema in a randomised controlled study. Forty-nine patients with parapneumonic empyema were randomly assigned to receive either intrapleural urokinase or normal saline treatment. The daily volume instilled through a chest tube was 100 ml in both groups. Urokinase (100,000 IU/day) was diluted in normal saline before instillation. The mean duration for defervescence was shorter (7 +/- 3 vs 13 +/- 5 days, p
Using a Saline Flush "Site Unseen" Could Lead to a Wrong-Route Error. [2020]Using a saline flush "site unseen" could lead to a wrong-route error.
Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use.
Taste and Odour Disturbances in Pediatric Patients Undergoing IV Flush with Normal Saline Administered by Prefilled or Freshly Prepared Syringes: Randomized Single-Blind Study. [2019]Previous studies have reported the occurrence of taste and odour disturbances among patients undergoing IV flush with prefilled syringes of 0.9% sodium chloride (normal saline [NS]). These disturbances have been attributed to the leaching of volatile substances into the NS from the plastic of the syringe. To date, there have been no studies comparing the occurrence of taste and odour disturbances with different NS preparations.
Efficacy of normal saline in the maintenance of the arterial lines in comparison to heparin flush: a comprehensive review of the literature. [2017]The aim of this study is to examine the efficacy of normal saline (0.9% sodium chloride) as a flush solution on patency of arterial lines in comparison to heparin flush. Data have been examined in various categories of specialty (medical, surgical, cardiac, burns, gynecology), frequency of flushes, strength and volume of flushes, continuous versus bolus, duration of each flush and patency incidence (range, ≤ 24 to ≥ 96 hours). The secondary aim focused on the incidences of reported heparin-induced thrombocytopenia (HIT type I and II).
Safety of a preservative-free acidified saline nasal spray: a randomized, double-blind, placebo-controlled, crossover clinical trial. [2015]To determine the safety and tolerance of a buffered preservative-free acidified solution as an alternative to standard chemical preservatives to prevent microbial contamination of saline nasal spray.
[Postoperative inhalation treatment after paranasal sinus interventions. A placebo-controlled, double-blind and randomized study]. [2015]A placebo-controlled, double-blind study with Ems brine inhalations as postoperative treatment after endoscopic endonasal sinus surgery was conducted on 30 patients. After informed consent had been obtained, the patients were treated with either Ems brine or saline solution (200 ml) 3 times a day for 10 days. The parameters measured were rhinomanometry, X-ray films of the sinuses, endoscopy, saccharin clearance and a subjective evaluation by the physician and by the patient based on a visual analogue scale. The difficulty of choosing parameters for assessing the treatment was that comparable clinical studies and a single predictive parameter were not available. The bacteriological test and the saccharin clearance test were not significantly different between the two groups. Recovery, swelling, crusting, bleeding and signs of inflammation, opacity on sinus X-ray films, and nasal flow as measured by rhinomanometry were all significantly better in the group inhaling brine solution (P less than 0.05).
Effect of irrigation of the nose with isotonic salt solution on adult patients with chronic paranasal sinus disease. [2019]In a prospective, randomized, controlled, double-blind trial we compared the effectiveness of endonasal irrigations with Ems salt solution to that with sodium chloride solution in the treatment of adult patients with chronic paranasal sinus disease. Subjects (n = 40) were randomly allocated to treatment either with isotonic Ems salt solution or with isotonic sodium chloride solution. The treatment consisted of endonasal irrigation twice daily and additional nasal spray as required. Nasal endoscopy, plain radiography of the paranasal sinuses, olfactometry, anterior rhinomanometry, and a saccharin-clearance test were carried out on days 1 and 7. Patients recorded rating scales of general discomfort, nasal airway obstruction, agreeableness of the irrigation, duration of improved nasal resistance after each irrigation, and the amount of additional nasal spray in a diary. Nasal air flow was not improved significantly. Subjective complaints, endonasal endoscopy, and radiography results revealed a significant improvement in both groups (P = 0.0001). In comparison, the two groups were not significantly different in outcome. Endonasal irrigations with salt solutions are effective in the treatment of chronic sinusitis, and a significant difference between Ems salt and sodium chloride was not observed.
Heparin versus saline flushing solutions in a small community hospital. [2022]Since no nursing policy on flushing procedures existed in their small community hospital, the authors thought it would be useful to clarify recent reports of the equivalency of saline to heparin flushes in their patient group before establishment of such a policy. They conducted a 2 month double-blinded, cross-over study of catheter failures when using either saline or heparin 10 units/mL flushing solutions. All medical and surgical floor patients were included in the study. Floor nurses were used as observers and characterized catheter failures as either loss of patency or phlebitis. Heparin was shown to cause more phlebitis than saline (p less than .025), but no difference was found between the two flushing solutions in loss of patency. Data revealed a statistically significant advantage to using saline flushes when both loss of patency and phlebitis were combined (p less than .05). They recommended adoption of a flushing procedure which did not contain heparin.
[Effectiveness and tolerance of nasal irrigation following paranasal sinus surgery]. [2015]Cleaning of the nose with saline solution after endonasal sinus surgery is very often used for postoperative treatment. But the efficiency and acceptance of this method has not been examined thoroughly until now.