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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complicated Pleural Effusion/ Empyema
• Intervention / Treatment: Drug: Saline pleural lavage; Drug: Sodium bicarbonate pleural lavage

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao Cao, Doctor; Phone Number: +86-0574-87089878; Email: caocdoctor@163.com
• Study Contact Backup: Name: Fang Liu; Phone Number: +86-0574-87089878; Email: liufangzju2010@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: Fang Liu; Phone Number: +86-0574-87089878; Email: liufangzju2020@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline group; Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days besides standard antibiotic therapy.	Drug: 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..
Experimental: Sodium bicarbonate group; Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days besides standard antibiotic therapy.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure rate of medical treatment (referral rate for surgery)	Week 2.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Pleural Thickness Before and After Treatment	Baseline, week 2, week 12 and 3-month follow up.
Volume of Pleural Effusion Before and After Treatment	Baseline, week 2, week 12 and 3-month follow up.
Average Length of Hospital Stay	Up to 3 months.
Inflammatory Response at 1 Week and 2 Weeks Post-Treatment	Baseline, week 1 and week 2.
All-Cause Mortality	Up to 3 months.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Ningbo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Inflammation; Suppuration; Pleural Diseases; Pleural Effusion; Empyema
• Other Study ID Numbers: 2024-R006-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No