the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Location status: Recruiting
NCT Number: NCT06734481
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Ningbo, Zhejiang, 315010, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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..
Time frame: Week 2.
Time frame: Baseline, week 2, week 12 and 3-month follow up.
Time frame: Baseline, week 2, week 12 and 3-month follow up.
Time frame: Up to 3 months.
Time frame: Baseline, week 1 and week 2.
Time frame: Up to 3 months.
Contact information is provided by the study sponsor or research team.
Chao Cao, Doctor
CONTACT
Fang Liu
CONTACT
First Affiliated Hospital of Ningbo University
Network
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
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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