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

NCT06734481 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-12-16

No results posted yet for this 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.

Conditions

  • Complicated Pleural Effusion/ Empyema

Interventions

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.

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..

Sponsors & Collaborators

  • First Affiliated Hospital of Ningbo University

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-05-01
Completion
2026-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734481 on ClinicalTrials.gov