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NCT Number: NCT06734481

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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..

Primary outcomes

  1. Failure rate of medical treatment (referral rate for surgery)

    Time frame: Week 2.

Secondary outcomes

  1. Change in Pleural Thickness Before and After Treatment

    Time frame: Baseline, week 2, week 12 and 3-month follow up.

  2. Volume of Pleural Effusion Before and After Treatment

    Time frame: Baseline, week 2, week 12 and 3-month follow up.

  3. Average Length of Hospital Stay

    Time frame: Up to 3 months.

  4. Inflammatory Response at 1 Week and 2 Weeks Post-Treatment

    Time frame: Baseline, week 1 and week 2.

  5. All-Cause Mortality

    Time frame: Up to 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Cao, Doctor

CONTACT

[email protected]

+86-0574-87089878

Fang Liu

CONTACT

[email protected]

+86-0574-87089878

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Official study title

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

Acronym: SAPLIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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