Prospective Study of Peripherally Inserted Venous Catheters in CF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Development of catheter related deep venous thrombosis or catheter occlusion
研究概览
简要总结
According to the U.S. CF Foundation Patient Registry, more than 25% of children and 40% of adults were treated with intravenous (IV) antibiotics for flares of lung disease in 2016. Medication for these flares is often delivered through a peripherally inserted central catheter (PICC). Case series have identified important complications of PICCs in CF patients such as blood clots and infection. The frequency of PICC-associated blood clots in CF patients ranges from 2 to 8%. Catheter-related complications may interfere with completion of therapy and lead to repeated procedures and other complex medical treatments. In some cases PICC complications may discourage patients from accepting future courses of IV antibiotics. Therefore, it is very important to identify patient- and device-related factors that are linked with more frequent complications and to figure out ways to reduce these risks. Proposed risk factors fall into several broad categories. First are catheter-related factors; second are patient factors; and third are catheter-management factors. To date, no multicenter trial has carefully studied PICC complications in a large group of adult and pediatric CF patients from the time each catheter is placed to when it is removed. The main purpose of this study is to see whether the investigators can identify important factors in each of the three categories (patient, catheter, and catheter management) that are linked to various complications.
详细描述
According to data from the U.S. CF Foundation Patient Registry (CFFPR), more than 25% of children and 40% of adults were treated with intravenous (IV) antibiotics for pulmonary exacerbations (PEx) in 2016; this translated to 20,286 care episodes. Case series have identified important complications of PICCs and TIVADs in CF patients such as deep venous thrombosis (DVT) and infection; central venous stenosis; and other types of mechanical dysfunction. The incidence of PICC-associated DVT in CF patients ranges from 2 to 8%. Proposed risk factors in CF patients fall into several broad categories. First are catheter-related factors: larger catheter size, number of catheter lumens, and catheter composition; second are patient factors: lung function, nutritional status, respiratory flora, diabetes status, thrombophilia; and number of previously placed catheters; and third are catheter-management factors: insertion technique and site selection, inpatient versus outpatient care, anticoagulant use, blood sampling practices, and duration of line use. The importance of some of these factors remains controversial, leading some to call for detailed prospective studies of PICC use in specific patient populations. To date, no multicenter trial has prospectively studied PICC and midline complications in adult and pediatric CF patients. The investigators hypothesize that the rate of PICC and midline vascular complications is associated with specific patient level and line level factors as well as with line insertion and management practices. The proposed trial is a multicenter, prospective surveillance study to evaluate (patient level-, catheter level- and catheter management-) risk factors associated with various complications of PICCs and midlines in pediatric and adult CF patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ethnic groups
- •Females and males
- •6 years of age and above (in order to perform spirometry on all study participants)
- •Undergoing treatment for PEx with IV antibiotics via hospital-placed PICC or midline catheter
- •Ability to communicate with pertinent staff.
- •Ability to understand and willingness to comply with the requirements of the trial (allow repeated assessment of the catheter insertion site, photographs of the site, extremity measurement and face-to face assessment on the day of line removal).
- •Ability and willingness to give verbal consent (with the assistance of a parent or guardian, if appropriate) or assent (for pediatric patients)
- •Diagnosis of cystic fibrosis consisting of both:
- •sweat sodium or chloride > 60 mEq/L by the pilocarpine iontophoresis method or cystic fibrosis genotype (homozygous for CFTR mutation or compound heterozygous for CFTR mutations)
- •clinical manifestations of cystic fibrosis
排除标准
- •Under age 6
- •Planned use of a TIVAD or peripheral catheter for IV therapy for the full course of therapy
- •History of >10 PICCs prior to study entry
- •IV treatment anticipated to extend beyond 21 days at the time of line insertion
- •Patient taking anticoagulant medication (other than NSAIDs) at the time of screening
- •Inability/unwillingness to provide consent or assent
结局指标
主要结局
Development of catheter related deep venous thrombosis or catheter occlusion
时间窗: While the catheter is in place, an average of two weeks
Occlusion of the catheter requiring removal or symptomatic venous thrombosis in the extremity with the line as indicated by a Constans Clinical Decision Score greater than or equal to 2. The range of the scale goes from -1 to 3 with higher scores representing worse outcome. One point is added to a baseline score of 0 for each of the following: indwelling venous material, localized pain, unilateral pitting edema. One point is subtracted for another diagnosis being at least as plausible as venous thrombosis.
次要结局
- Central line associated blood stream infection (CLABSI)(While the catheter is in place, an average of two weeks)
- Number of participants with catheter associated deep venous thrombosis(While the catheter is in place, an average of two weeks)
- Development of catheter related local phlebitis or superficial thrombophlebitis(While the catheter is in place, an average of two weeks)
研究者
Jonathan B. Zuckerman
Director, Adult Cystic Fibrosis Program
MaineHealth