Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cystic Fibrosis
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 6 years and 125 years
- Gender
- Both males and females
Description
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 o...
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.
Tracking Information
- NCT #
- NCT03674216
- Collaborators
- MaineHealth
- Cystic Fibrosis Foundation
- Investigators
- Principal Investigator: Jonathan Zuckerman, M.D. MaineHealth