Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients (PICC-CF)

April 8, 2022 updated by: Jonathan B. Zuckerman

Prospective Study of Peripherally Inserted Venous Catheters in CF Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 040102
        • Maine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric and adult cystic fibrosis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development of catheter related deep venous thrombosis or catheter occlusion
Time Frame: 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.
While the catheter is in place, an average of two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of catheter related local phlebitis or superficial thrombophlebitis
Time Frame: While the catheter is in place, an average of two weeks
Phlebitis as defined by a Visual Infusion Phlebitis (VIP) score greater than or equal to 2. The range of the scale goes from 0 to 5 with higher scores representing worse outcome. The values on the VIP scale are defined as follows: 0-site appears healthy; 1- One of the following: Pain near the IV site or erythema near the IV site; 2- Two of the following: Pain or erythema or swelling near the IV site; 3- All of the following: Pain, erythema, and induration near the IV site; 4- All of the following: Pain, erythema, and palpable venous cord near the IV site; 5- All of the following: Pain, erythema, palpable venous cord and fever >38 degrees centigrade. Thrombophlebitis is defined by phlebitis associated with superficial thrombosis as detected by ultrasound or venogram.
While the catheter is in place, an average of two weeks
Central line associated blood stream infection (CLABSI)
Time Frame: While the catheter is in place, an average of two weeks
The study definition for CLABSI follows the Centers for Disease Control guidelines
While the catheter is in place, an average of two weeks
Number of participants with catheter associated deep venous thrombosis
Time Frame: While the catheter is in place, an average of two weeks
Deep venous thrombosis as confirmed by ultrasound and/or venogram
While the catheter is in place, an average of two weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with catheter associated hematoma or bleeding
Time Frame: While the catheter is in place, an average of two weeks
Visible bruising associated with the catheter insertion site, bleeding from the catheter insertion site or incident hemoptysis
While the catheter is in place, an average of two weeks
Number of patients with catheter associated site pain
Time Frame: While the catheter is in place, an average of two weeks
Pain in the extremity associated with the catheter
While the catheter is in place, an average of two weeks
Number of patients with catheter fracture
Time Frame: While the catheter is in place, an average of two weeks
Catheter fracture
While the catheter is in place, an average of two weeks
Number of patients with temporary occlusion of the catheter
Time Frame: While the catheter is in place, an average of two weeks
Temporary occlusion of the catheter cleared by thrombolytic agent
While the catheter is in place, an average of two weeks
Catheter associated change in arm circumference
Time Frame: While the catheter is in place, an average of two weeks
Arm circumference in centimeters (cm) measured 5 cm distal to the catheter insertion site
While the catheter is in place, an average of two weeks
Serum C-reactive protein concentration
Time Frame: While the catheter is in place, an average of two weeks
Serum measure of inflammatory status with samples taken at the time of catheter insertion and removal
While the catheter is in place, an average of two weeks
Serum D-dimer concentration
Time Frame: While the catheter is in place, an average of two weeks
Blood test to assess coagulation status with samples taken at the time of catheter insertion.
While the catheter is in place, an average of two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jonathan B. Zuckerman

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cystic Fibrosis Foundation
MaineHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Zuckerman, M.D., MaineHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1223366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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