Using sodium bicarbonate to treat complex pleural effusion

Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion: Protocol for a Multicenter Randomized Controlled Trial（SAPLIC Study）

This study is testing if using sodium bicarbonate instead of saline for washing out fluid in the lungs can help adults with complicated pleural effusion recover better and avoid surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Ningbo University (Research network)
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT06734481 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18 to 80 with specific criteria for complicated pleural effusion and significant fluid accumulation.

Not a fit: Patients with severe heart or kidney failure, known allergies to sodium bicarbonate, or those with pleural effusion from certain infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce the need for surgery and enhance recovery for patients with complicated pleural effusion.

How similar studies have performed: While the use of sodium bicarbonate in this context is novel, similar approaches in pleural effusion management have shown promise in other studies.

Eligibility criteria

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 this trial is running

Ningbo, Zhejiang

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

Study contacts

• Study coordinator: Chao Cao, Doctor

Conditions Complicated Pleural Effusion/ Empyema