Using sodium bicarbonate to treat complex pleural effusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of sodium bicarbonate pleural lavage in adults with complicated pleural effusion. Participants will undergo catheter placement for continuous drainage, followed by either saline or sodium bicarbonate lavage over a week. The study aims to determine if sodium bicarbonate can reduce the need for surgical intervention and improve patient recovery and prognosis. The trial includes patients with specific criteria for complicated pleural effusion, ensuring a targeted approach to treatment.

Why it matters

Who can join: the full rules

Inclusion 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 \< 7.2; B. Pleural fluid glucose \< 2.2 mmol/L and LDH \> 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 indicated according to established guidelines or criteria.

Exclusion Criteria:

* 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 efficacy, 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.

Where it's running

• the First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Chao Cao, Doctor
• Email: caocdoctor@163.com
• Phone: +86-0574-87089878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.