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

NCT06734481 | Recruiting DMC

• 1 other identifier: 2024-R006-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complicated Pleural Effusion/ Empyema

Outcome Measures

Primary Outcomes (1)

• Failure rate of medical treatment (referral rate for surgery)

  Week 2.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Saline group

PLACEBO COMPARATOR

Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days besides standard antibiotic therapy.

Drug: Saline pleural lavage

Sodium bicarbonate group

EXPERIMENTAL

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

Interventions

Sodium bicarbonate pleural lavage DRUG

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.

Sodium bicarbonate group

Saline pleural lavage DRUG

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..

Saline group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 \< 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (1)

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

Central Study Contacts

Chao Cao, Doctor

CONTACT

+86-0574-87089878; caocdoctor@163.com

Fang Liu

CONTACT

+86-0574-87089878; liufangzju2010@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)