Cystic FibrosisPICC-CFNCT03674216
Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by Jonathan B. Zuckerman at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult cystic fibrosis patients
Who may be able to join
- 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).
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- peripherally inserted central venous catheter, midline catheter, thrombosis, blood stream infection
- Medical subject headings
- Cystic Fibrosis, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of catheter related deep venous thrombosis or catheter occlusion
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.
Measured: While the catheter is in place, an average of two weeks
Secondary outcomes (3)
Development of catheter related local phlebitis or superficial thrombophlebitis
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.
Measured: While the catheter is in place, an average of two weeks
Central line associated blood stream infection (CLABSI)
The study definition for CLABSI follows the Centers for Disease Control guidelines
Measured: While the catheter is in place, an average of two weeks
Number of participants with catheter associated deep venous thrombosis
Deep venous thrombosis as confirmed by ultrasound and/or venogram
Measured: While the catheter is in place, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start12 Nov 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan B. Zuckerman
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Jonathan B. Zuckerman, MaineHealth
- Investigators
- Jonathan Zuckerman, M.D., Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674216
- Sponsor's protocol ID
- 1223366
- Acronym
- PICC-CF
- Status last verified
- Apr 2022
- First submitted
- 12 Sep 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Peripherally Inserted Venous Catheters in CF Patients
- ClinicalTrials.gov ID
- NCT03674216
- Acronym / sponsor ID
- PICC-CF / 1223366
- Conditions
- Cystic Fibrosis
- Keywords
- peripherally inserted central venous catheter, midline catheter, thrombosis, blood stream infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Jonathan B. ZuckermanUniversity, hospital or other
- Collaborators
- MaineHealth, Cystic Fibrosis Foundation
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult cystic fibrosis patients
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Development of catheter related local phlebitis or superficial thrombophlebitis
Time frame: 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
Number of participants with catheter associated deep venous thrombosis
Time frame: While the catheter is in place, an average of two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Zuckerman, M.D. principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Jonathan B. Zuckerman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of catheter related deep venous thrombosis or catheter occlusion (time frame: While the catheter is in place, an average of two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.