Management of Pleural Space Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation
研究概览
简要总结
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
详细描述
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
Patient's with complex pleural space infections identified at the institution that meet inclusion criteria will be randomized to receive either IPFT or surgical debridement after a surgery consultation is obtained. Patients randomized to the IPFT study arm will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg BID x 3 days delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase). The surgical arm will have either open surgery of a VATS approach at the discretion of the surgeon.
IPFT (alteplase and DNase) is not an investigational agent. It is used in standard of care practice for the treatment of complex pleural space infections. The investigators seek to compare dual-agent IPFT (alteplase and DNase) to surgery in this study. As such, the IPFT agents will be ordered from pharmacy through the electronic medical record (EMR) as in normal practice and there is not a study drug.
After drainage, patients will be followed with protocol images to assess the drainage of their pleural space. If there is satisfactory improvement in the pleural fluid collection on imaging chest tube or small bore catheter will be removed per protocol in both study arms. Chest tube removal protocol is based on fluid character and measured output.
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
- 是
入选标准
- •Age >18 years
- •Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP))
- •Pleural fluid requiring drainage that is either:
- •Macroscopically purulent or
- •Positive on culture for bacterial infection or
- •Positive for bacteria on gram stain or
- •Lactate dehydrogenase (LDH) > 1000 IU/L or
- •Glucose <40 mg/dL
排除标准
- •Age <18 years
- •Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study)
- •Not proficient in English
- •History of prior ipsilateral empyema
- •Has known sensitivity to DNase or alteplase
- •History of intracranial hemorrhage or acute intracranial hemorrhage
- •History of stroke, hemorrhage, or trauma within the last 3 months
- •Has had prior surgery on the side of the pleural infection
- •Patients who are pregnant or lactating
- •Expected survival less than 6 months from a different pathology to this pleural infection based on clinical judgment
- •Has a tunneled pleural catheter in place
- •Patients on anticoagulation that cannot be interrupted for surgical intervention
- •Patients with known or suspected malignant pleural effusion
- •Patients with renal failure (Creatinine clearance <30)
- •Prior history of or concern for chylothorax or pseudochylothorax
- •Vulnerable populations: prisoners
研究组 & 干预措施
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Intrapleural Medications (Drug)
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Pleural Sampling (Procedure)
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Pleural fluid drainage (Procedure)
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Protocol Image #1 (Radiation)
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Surgical Consultation (Other)
Intrapleural fibrinolytic therapy (IPFT)
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage
- Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Quality of Life (Behavioral)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Surgery (Procedure)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Pleural Sampling (Procedure)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Pleural fluid drainage (Procedure)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Protocol Image #1 (Radiation)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Surgical Consultation (Other)
Surgery
- Procedure/Surgery: Pleural Sampling
- Procedure/Surgery: Pleural fluid drainage: Chest tube placement
- Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
- Other: Surgical Consultation
- Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
- Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
- Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
干预措施: Quality of Life (Behavioral)
结局指标
主要结局
Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation
时间窗: From patient identification to 1 year post discharge
• Test the feasibility of the proposed study algorithm to compare Intrapleural fibrinolytic therapy (IPFT) to surgical intervention as measured by percent enrollment to completion of study algorithm and multidisciplinary participation in adherence to the algorithm.
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
时间窗: From patient identification to 1 year post discharge
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
次要结局
- Radiographic improvement(From date of protocol Image #1 (once the chest tube is placed, protocol image #1 is obtained within 24-48 hours) to date of protocol Image #2 (the morning after intervention, approximately 12-24 hours after intervention))
- Chest tube duration(From date of initiation of intervention of IPFT or surgery (approximately 24-48 hours after patient identification) to date of removal of chest tube, approximately 7 days after placement depending on the intervention and the chest tube output.)
- Number of participants with procedure related complications(From intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days)
- Cost comparison(From date of intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days)
- Number of participants who have treatment failures needing further treatment crossover (IPFT to surgery; surgery to IPFT)(From patient identification to 1 year post discharge)
- Quality of life Surveys: 36-Item Short Form Survey (SF-36)(Quality of life will be measured at 30 day and 90 day clinical follow-up)