Comparative Efficacy of Sequential VATS and Streptokinase Therapy versus streptokinase followed by VATS in Paediatric Empyema.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Clinical resolution of symptoms such as fever and respiratory distress evidenced by the patient being afebrile for the last 24 hours and having ICD drainage of less than 15 ml in the last 24 hours.
研究概览
简要总结
Background: Empyema thoracis in pediatric populations poses a significant healthcare challenge, characterized by the accumulation of infected fluid in the pleural cavity. Video-assisted thoracoscopic surgery (VATS), complemented by chest tube drainage and antibiotics, has been the standard treatment. However, some cases persist with infection and inflammation post-VATS, necessitating further intervention. Streptokinase, known for its fibrinolytic properties, offers potential as an adjunct therapy, but its efficacy post-VATS remains underexplored.
Novelty: This study introduces a novel approach to treating pediatric thoracic empyema by evaluating the sequential administration of VATS and Streptokinase against the standard sequence (Streptokinase followed by VATS). The novelty lies in investigating whether the order of these treatments impacts the effectiveness in resolving empyema, a question not previously addressed in existing literature.
Objectives: The primary objective is to compare the average number of days with drainage between the two treatment groups. Secondary objectives include assessing differences in empyema resolution rates, complication frequencies, and recurrence within a 6-month period.
Methods: A randomized controlled trial will be conducted over three years, involving 46 pediatric patients with Stage II or early-Stage III thoracic empyema. Participants will be allocated to either VATS followed by Streptokinase or the standard sequence. Primary and secondary outcomes
will be analysed using statistical tests, including survival analysis to determine median time to drainage and risk factors for delayed resolution.
Expected Outcome: The study anticipates showing a significant difference in drainage duration between the two treatment sequences, potentially offering a more effective treatment protocol for pediatric empyema. These findings could lead to revised clinical guidelines and improved patient outcomes in this challenging medical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 month to 15 years with a clinical diagnosis of Stage II or early-Stage III thoracic empyema.
- •No previous use of Streptokinase.
- •Pleural thickening less than 5 mm confirmed through USG and CECT Thorax.
- •Presence of unilateral loculated pleural effusion with septation.
排除标准
- •Known hypersensitivity or contraindications to Streptokinase.
- •Children with a medical history of congenital vascular anomalies, hypoxic-ischemic encephalopathy, arteriovenous malformation, or bronchopleural fistula.
- •Presence of other severe comorbidities or conditions of immunosuppression.
结局指标
主要结局
Clinical resolution of symptoms such as fever and respiratory distress evidenced by the patient being afebrile for the last 24 hours and having ICD drainage of less than 15 ml in the last 24 hours.
时间窗: 6 hours 24 hours 48 hours
Radiological measures involving lung expansion, assessed through imaging at 6 and 48 hours post VATS. Minimal lung expansion should be 80%.
时间窗: 6 hours 24 hours 48 hours
次要结局
- Time to full resolution of empyema, measured in days post-intervention. Presence or absence of complications such as bleeding or other infections resulting from the Streptokinase injection.
研究者
Rashi
All India Institute of Medical Sciences Patna