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临床试验/NCT03583931
NCT03583931已完成不适用

Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication

Denver Health and Hospital Authority1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Hospital Length of Stay

研究概览

简要总结

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.

详细描述

The treatment of parapneumonic infections (infection in the pleural space) at the Denver Health Medical Center is not standardized, and timing for advanced interventions such as fibrinolytic therapy or surgical decortication remain unclear. The definitive treatment strategy in these patients may be sub-optimal, and lead to prolonged hospitalization and morbidity. This is concerning as the mortality rate of community acquired pneumonia triples in the presence of a parapneumonic process (5-15%) and can reach over 25% if it becomes bilateral(1). Prompt recognition of pleural space infections is essential for reducing morbidity and mortality. This is attributable to the progression of the disease from a simple fluid collection amenable to pleural space drainage, to necrotizing empyema requiring thoracotomy decortication and open drainage. The keys to management of parapneumonic effusions are early diagnosis, appropriate therapeutic intervention, and recognition of failure of conservative management. The investigators propose that a standardized pathway for identifying and treating parapneumonic effusions will be an important quality improvement. A key gap in the literature remains if patients with parapneumonic infections that cannot be drained with a chest tube should undergo a trial in intrapleural fibrinolytic therapy, or if they should go directly to video assisted thoracic surgery (VATS) for decortication of all infectious material.

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

入选标准

  • 18 years old and older
  • Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
  • Pleural fluid pH <7.3
  • SICU placed chest tube
  • Subsequent transfer to SICU

排除标准

  • Existing malignancy
  • Malignant cells from initial pleural fluid sample
  • End stage liver disease (Child's B or greater)
  • Coagulopathy
  • Unable to tolerate surgical procedure
  • Frank purulent drainage (needs OR regardless)
  • Recent surgery of abdomen or thorax precluding the use of tPA
  • Baseline neurologic impairment requiring a proxy for consent

研究组 & 干预措施

Operative VATS decortication

Active Comparator

Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema

干预措施: VATS Decortication (Procedure)

Non-operative Fibrinolytic Therapy

Active Comparator

Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.

干预措施: Fibrinolytic Therapy (Drug)

结局指标

主要结局

Hospital Length of Stay

时间窗: From patient's admission to hospital to their discharge, (excluding extended stay due to social work reasons) up to 28 days or discharge, which ever comes first.

How long the patient remains admitted in the hospital during their index hospitalization

次要结局

  • Days of Antibiotics(From admission to discharge, or for 28 days, whichever comes first.)
  • Changed in Coagulopathic Status(From admission to discharge, or for 28 days, whichever comes first.)
  • ICU Free Days(From admission to discharge, or for 28 days, whichever comes first.)
  • Chest Tube Days(From admission to discharge, or for 28 days, whichever comes first.)
  • Incentive Spirometry(Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.)
  • Pain Score(From admission to discharge, or for 28 days, whichever comes first.)
  • Elevated White Blood Count Days(From admission to discharge, or for 28 days, whichever comes first.)
  • Cost of Admission and Treatment(From admission to discharge, or for 28 days, whichever comes first.)
  • Chest Tube Drainage(From admission to discharge, or for 28 days, whichever comes first.)
  • Supplemental Oxygen Days(From admission to discharge, or for 28 days, whichever comes first.)
  • Fever Days(From admission to discharge, or for 28 days, whichever comes first.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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