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Tests treatment safety and results for Complicated Pleural Effusion/ Empyema
Official title Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion
ClinicalTrials.gov ID: NCT06734481
What this study is testing
What is Sodium bicarbonate pleural lavage?
Sodium bicarbonate pleural lavage is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for complicated pleural effusion/ empyema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety and efficacy of sodium bicarbonate pleural lavage in treating complex pleural effusion in adult. The main questions it aims to answer are: Will sodium bicarbonate pleural lavage reduce the failure rate of medical treatment (referral rate for surgery) for complicated pleural effusion？ Can sodium bicarbonate pleural lavage accelerating the rehabilitation of patients with complicated pleural effusion？ Will sodium bicarbonate pleural lavage improve the prognosis of patients with complicated pleural effusion?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Hospitalized patients aged 18 to 80 years, inclusive.
- Patients fulfilling any one of the following three criteria for complicated pleural effusion: A. Pleural fluid pH \ 1000 IU/L; C. Positive pleural...
- Pleural effusion volume exceeding 300 mL, as determined by CT imaging using the formula D\^2 \ L (where D represents the maximum depth and L the...
You likely can't join if
- Patients with known allergies to sodium bicarbonate or normal saline.
- Patients with severe coagulation disorders.
- Patients with severe heart or kidney failure.
- Pregnant or lactating women.
- Patients with pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes.
- Patients unable to tolerate intrapleural administration.
See the full eligibility criteria
- Hospitalized patients aged 18 to 80 years, inclusive.
- Patients fulfilling any one of the following three criteria for complicated pleural effusion: A. Pleural fluid pH \ 1000 IU/L; C. Positive pleural fluid culture or smear for pathogens.
- Pleural effusion volume exceeding 300 mL, as determined by CT imaging using the formula D\^2 \ L (where D represents the maximum depth and L the maximum length), and for whom pleural effusion drainage is clinically...
- Patients with known allergies to sodium bicarbonate or normal saline.
- Patients with severe coagulation disorders.
- Patients with severe heart or kidney failure.
- Pregnant or lactating women.
- Patients with pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes.
- Patients unable to tolerate intrapleural administration.
- Patients with chronic lung diseases that may affect antibiotic how well it works, such as uncontrolled chronic obstructive pulmonary disease (COPD GOLD E group), bronchiectasis, or immunodeficiency.
- Patients who have experienced shock, major bleeding, trauma, or pulmonary surgery within the past 5 days.
- Patients with a history of lung or pleural surgery on the side of the pleural effusion.
- Patients who have recently had chest tubes placed due to pneumothorax, surgery, or pleural effusion.
- Patients currently enrolled in another drug or device clinical trial.
- Patients with poor compliance or difficulty in follow-up, or those with an expected survival of less than 3 months due to conditions other than pleural effusion.
The study team makes the final eligibility decision.
Where it's taking place
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.