Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion: Protocol for a Multicenter Randomized Controlled Trial（SAPLIC Study）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Failure rate of medical treatment (referral rate for surgery)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Saline group
Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days besides standard antibiotic therapy.
干预措施: Saline pleural lavage (Drug)
Sodium bicarbonate group
Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days besides standard antibiotic therapy.
干预措施: Sodium bicarbonate pleural lavage (Drug)
结局指标
主要结局
Failure rate of medical treatment (referral rate for surgery)
时间窗: Week 2.
次要结局
- Change in Pleural Thickness Before and After Treatment(Baseline, week 2, week 12 and 3-month follow up.)
- Volume of Pleural Effusion Before and After Treatment(Baseline, week 2, week 12 and 3-month follow up.)
- Average Length of Hospital Stay(Up to 3 months.)
- Inflammatory Response at 1 Week and 2 Weeks Post-Treatment(Baseline, week 1 and week 2.)
- All-Cause Mortality(Up to 3 months.)
研究者
Caochao
Principal Investigator
First Affiliated Hospital of Ningbo University