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Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients

NCT03674216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2022-04-11

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Jonathan B. Zuckerman

    lead OTHER

Principal Investigators

  • Jonathan Zuckerman, M.D. · MaineHealth

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674216 on ClinicalTrials.gov