Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Reduction in Pleural Effusion Volume
研究概览
简要总结
The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections.
The specific aims of the study include:
Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention.
Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.
详细描述
Objective:
To evaluate the efficacy and safety of pleural saline irrigation as an adjunct therapy in patients with retained pleural infection, comparing it with the standard of care (antibiotics, chest tube placement, and lytics).
Study Design:
This is a prospective, two-arm pilot trial to be conducted at Beth Israel Deaconess Medical Center. The study will involve two groups: one receiving standard care and the other receiving pleural saline irrigation in addition to standard care. Patients will be assigned to one of the two study arms (standard care vs. standard care + saline irrigation) using block randomization to ensure balanced group sizes.
Interventions:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
- •Glucose < 40 mg/dL.
- •LDH > 1000 IU/L.
- •Presence of bacterial or fungal organisms on Gram stain or culture.
- •Chest tube placement with less than 200 mL drainage in 24 hours.
- •Indication for IPFT treatment based on treating physician's criteria.
- •Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).
排除标准
- •Inability to provide informed consent.
- •Pregnant patients.
- •Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
- •Complicated sympathetic effusion.
- •Hepatic hydrothorax.
研究组 & 干预措施
Standard of care
Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA/DNase therapy based on their clinical criteria
Standard Care + Saline Irrigation
In addition to the standard care, patients in this group will receive pleural saline irrigation through the chest tube immediately after IPFT. The amount of saline will be determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated every time that IPFT is administered, based on treating physician's criteria
干预措施: Pleural Saline Irrigation (Combination Product)
结局指标
主要结局
Reduction in Pleural Effusion Volume
时间窗: Baseline (prior to intervention). During hospitalization (before each IPFT and irrigation session, anticipated every 24 hours, up to 14 days). At discharge (7-14 days post-intervention initiation). Follow-up at 3 weeks (+/- 3 days) and 6 weeks (+/- 3 day
This outcome assesses the percentage reduction in pleural effusion volume from baseline, measured by CT (volumetry) and ultrasound using the Balik formula. Efficacy is defined as a 10% or greater improvement in pleural effusion volume reduction in the intervention group (standard care plus pleural saline irrigation) compared to the control group (standard care alone). Success is determined by achieving a ≥10% additional reduction in pleural effusion volume in the intervention group compared to the control group, indicating a clinically meaningful improvement with adjunctive saline irrigation.
次要结局
- Rate of pleural infection resolution(Baseline, at discharge (7-14 days post-intervention initiation), and follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge).)
- Chest tube duration(Through hospitalization (up to 14 days).)
- Length of hospital stay(Through hospitalization (anticipated 7-14 days).)
- Complications related to the interventions(During hospitalization (up to 14 days) and at follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge).)
- Pain associated with interventions(During hospitalization (measured immediately after each intervention session, anticipated up to 14 days).)
- Need for surgical intervention(Through study completion (up to 6 weeks post-discharge).)
- Overall mortality(Through study completion (up to 6 weeks post-discharge).)
研究者
Adnan Majid, MD
Medical Doctor
Beth Israel Deaconess Medical Center