Clinical Trial

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

Study acronym: SAPLIC
Recruiting
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Record status
This record was last updated December 16, 2024 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06734481
Lead Sponsor First Affiliated Hospital of Ningbo University
Conditions Complicated Pleural Effusion/ Empyema
Enrollment 260 participants
Start Date 2024-04-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-16