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Clinical Trials in China / NCT06734481
Recruiting Not applicable

Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion

NCT06734481 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Ningbo University
Phase
Not applicable
Started
2024-04-01
Last updated
2024-12-16

Condition(s) studied

Complicated Pleural Effusion/ Empyema

Investigational drug(s) / intervention(s)

Sodium bicarbonate pleural lavageSaline pleural lavage

Sodium bicarbonate pleural lavage: All participants will receive a standardized antimicrobial therapy regimen, with antibiotics selected based on susceptibility testing. Within 2 days of initiating treatment, all patients will undergo catheter placement for continuous drainage of pleural effusion. Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days. For patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage.Following each daily injection, the catheter will be clamped for 2 hours before resuming continuous drainage, a process that will continue for 7 days.

Saline pleural lavage: All participants will receive a standardized antimicrobial therapy regimen, with antibiotics selected based on susceptibility testing. Within 2 days of initiating treatment, all patients will undergo catheter placement for continuous drainage of pleural effusion. Participants will receive a daily intrapleural injection of 200 mL of saline in 7days For patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage. Following each daily injection, the catheter will be clamped for 2 hours before resuming continuous drainage, a process that will continue for 7 days..

Study summary

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?

Participants will will undergo catheter placement for continuous drainage of pleural effusion. Once at least 200 mL of pleural effusion has been drained:

Group A: Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days; Group B: Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the First Affiliated Hospital of Ningbo University Ningbo Zhejiang Recruiting

More First Affiliated Hospital of Ningbo University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734481 on ClinicalTrials.gov ↗ ← All trials in China