Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Length of hospital stay
研究概览
简要总结
Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%.
Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung.
The initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike.
Current standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence.
The aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life.
The present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally.
It is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators/consultants who will provide counselling in connection with the study.
详细描述
Intrapleural Fibrinolysis and DNase versus VATS for the treatment of pleural empyema: a randomized, controlled trial
BACKGROUND
Pleural empyema is a disease with an infection inside the chest cavity, often as a result of a pneumonia. In Denmark there are approximately 500 new cases per year. Patients often have longer duration of hospitalization, and the disease carries a significant morbidity and mortality rate of approximately 15%. The state of pleura empyema is characterized by the passage of three stages (I - III):
- Parapneumonic effusion (stage I)
- Fibropurulent stage (stage II)
- Chronic organizing stage (stage III)
The aim of treating the disease is to remove the infection and provide fully expansion of the lung.
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
- •18 years or more on the day of hospitalization
- •Must be able to provide informed consent
- •Acute hospitalization within the last 48 hours
- •Meeting diagnostic criteria for community acquired pleural infection using the following criteria:
- •A clinical presentation compatible with pleural infection AND
- •Has pleural fluid which is either:
- •purulent pleural fluid or
- •gram stain positive or
- •culture positive or
- •acidic with pH < 7.2 or
- •low pleural fluid glucose (< 2 mmol/L) in the absence of accurate pH measurement or
- •septated pleural fluid on ultrasound
排除标准
- •• Pregnancy. Prior to inclusion of fertile women (defined as the period from menarche to postmenopause) a negative pregnancy test must be available
- •Breastfeeding
- •Declared terminally ill or a predicted survival of less than 3 months
- •Previous intrathoracic surgery (within <1 year on the same side of the thorax as where the parapneumonic effusion/pleural empyema is located
- •Previously (within <1 year) hospitalized with with complex parapneumonic effusion (stage II) or pleural empyema (stage III)
- •Drainage during the current admission on the same side of the thorax (excluding diagnostic pleural puncture)
- •Hospitalization within 7 days prior to current hospitalization
- •Previous allergic reaction to alteplase or DNase
- •Use of alteplase therapy contraindicated:
- •Ongoing treatment with oral anticoagulant incl. new oral anticoagulants (e.g. warfarin (Marevan), Dabigatranetexilat (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Endoxaban (Lixiana))
- •Significant ongoing bleeding or within last six months
- •Known haemorrhagic diathesis
- •Previous or suspected intracranial hemorrhage
- •Suspected subarachnoidal hemorrhage or condition following subarachnoidal hemorrhage from aneurysm
- •All forms of damage to the central nervous system (e.g. cerebral tumors, aneurysm, intracranial / spinal surgery)
- •Recent (within 10 days) cardiac resuscitation, birth, or perforation of non-compressible blood vessel (e.g. puncture of v. subclavia, v. jugularis)
- •Severe, uncontrolled arterial hypertension
- •Bacterial endocarditis, pericarditis
- •Acute pancreatitis
- •Documented ulcerative gastrointestinal disease within last 3 months, esophagal varices, arterial aneurysm, arterio-venous malformations
- •Tumor / malignancy with an increased risk of hemorrhage
- •Severe liver disease, including liver failure cirrhosis, portal hypertension (esophagal varices), and active hepatitis
- •Large operation or significant trauma within previous 3 months
结局指标
主要结局
Length of hospital stay
时间窗: Through study completion, an average of 1 year
Admission time is defined as the time from first admission in the course of the hospitalization and to the completion of treatment defined as time of discharge from hospital without need of any additional invasive treatment.
次要结局
- Length of hospital stay after commencement of intervention(Through study completion, an average of 1 year)
- Length of hospital stay in subgroups(Through study completion, an average of 1 year)
- Days at home up to 30 days after intervention (DAH30) treatment(Through study completion, an average of 1 year)
- 30-day and in-hospital mortality(Through study completion, an average of 1 year)
- Proportion of patients where primary intervention could be considered as definitive treatment(30 days)
- Complications ranked by Clavien-Dindo classification and Comprehensive Complication Index (CCI)(Through study completion, an average of 1 year)
- Quality of life and patient reported outcomes within 12 months after hospitalization(Through study completion, an average of 1 year)
- Need for additional thoracic surgery within 12 months after hospitalization(1 year)
- Consumption of painkillers during hospitalization and within 12 months after hospitalization(Through study completion, an average of 1 year)
- Lung physiology within 12 months after hospitalization(1 year)
- Health related costs(1 year)
研究者
Thomas Decker Christensen
Consultant, Professor, MD, DMSc., Ph.D
Aarhus University Hospital