Clinical trial NCT03674216: Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients
Official title: Prospective Study of Peripherally Inserted Venous Catheters in CF Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: peripherally inserted central venous catheter
midline catheter
thrombosis
blood stream infection
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
name: Cystic Fibrosis Foundation
First posted: 2018-09-17
Enrollment: 260
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult cystic fibrosis patients

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Development of catheter related deep venous thrombosis or catheter occlusion
timeFrame: While the catheter is in place, an average of two weeks
Secondary outcomes:
measure: Development of catheter related local phlebitis or superficial thrombophlebitis
timeFrame: While the catheter is in place, an average of two weeks
measure: Central line associated blood stream infection (CLABSI)
timeFrame: While the catheter is in place, an average of two weeks
measure: Number of participants with catheter associated deep venous thrombosis
timeFrame: While the catheter is in place, an average of two weeks
Other outcomes:
measure: Number of patients with catheter associated hematoma or bleeding
timeFrame: While the catheter is in place, an average of two weeks
measure: Number of patients with catheter associated site pain
timeFrame: While the catheter is in place, an average of two weeks
measure: Number of patients with catheter fracture
timeFrame: While the catheter is in place, an average of two weeks
measure: Number of patients with temporary occlusion of the catheter
timeFrame: While the catheter is in place, an average of two weeks
measure: Catheter associated change in arm circumference
timeFrame: While the catheter is in place, an average of two weeks
measure: Serum C-reactive protein concentration
timeFrame: While the catheter is in place, an average of two weeks
measure: Serum D-dimer concentration
timeFrame: While the catheter is in place, an average of two weeks
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Jonathan Zuckerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: