Actively Recruiting
Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion
Led by First Affiliated Hospital of Ningbo University · Updated on 2024-12-16
260
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patients aged 18 to 80 years, inclusive
- Diagnosis of complicated pleural effusion with at least one of the following: pleural fluid pH less than 7.2; pleural fluid glucose below 2.2 mmol/L and LDH above 1000 IU/L; or positive pleural fluid culture or smear
- Pleural effusion volume greater than 300 mL as measured by CT imaging, requiring drainage based on guidelines
You will not qualify if you...
- Known allergy to sodium bicarbonate or normal saline
- Severe coagulation disorders
- Severe heart or kidney failure
- Pregnant or breastfeeding women
- Pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes
- Unable to tolerate intrapleural treatment
- Chronic lung diseases affecting antibiotic treatment such as uncontrolled COPD GOLD E group, bronchiectasis, or immunodeficiency
- Shock, major bleeding, trauma, or pulmonary surgery within the past 5 days
- History of lung or pleural surgery on the side with pleural effusion
- Recent chest tube placement for pneumothorax, surgery, or pleural effusion
- Participation in another drug or device clinical trial
- Poor compliance or difficulty with follow-up
- Expected survival less than 3 months due to other conditions
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
C
Chao Cao, Doctor
CONTACT
F
Fang Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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