Vascular Access ComplicationNCT04136561
Novel Strategy to Encourage Early Removal of Central Venous Catheters
A study testing Midline catheter in people with Vascular Access Complication and Central Line Complication, run by Corewell Health East at 1 site in United States.
Trial summary
The goal of this study is to determine if early placement of a midline catheter in patients with a central venous catheter (CVC) will decrease the number of days the CVC is in place. Patients who are in the medical intensive care unit (MICU) and have a CVC may be approached to join the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Central Line Complication, Central Line-Associated Infection
- What is being tested?
- Midline catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years of age or older admitted to the MICU at Beaumont Hospital- Royal Oak who require a CVC Midline placement by the vascular access team within 24 hours of CVC placement
Who cannot join
- Patients not admitted to MICU
- Patients < 18 years of age
- Patients identified to require a PICC for extended duration of therapy
- Patients with midline catheters, pre-existing ports, dialysis catheters (Quinton), or other vascular access already inserted within the first 24 hours of CVC insertion (peripheral IV catheters are allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
The goal of this study is to determine if early placement of a midline catheter in patients with a central venous catheter (CVC) will decrease the number of days the CVC is in place. Patients who are in the medical intensive care unit (MICU) and have a CVC may be approached to join the study. Those who meet study eligibility and provide written consent will be enrolled. The longer the CVC remains in place,the greater the chance of developing an infection or blood clot. Any IV line that is placed (CVC, midline, peripheral line) comes with the risk of infection or blood clots, although that risk is generally less with the midline and peripheral IV lines than a CVC. The treating team will make the decision when to remove the CVC. The timeline of removal will be compared to previous data collected on patients similar to the ones in this study. During their hospital stay, study patients will be monitored for how well the midline catheter is functioning as well as if they develop a catheter related blood clot or infection.
Read the detailed description
Central line-associated bloodstream infection (CLABSI) remains a serious problem contributing to patient morbidity and mortality. These potentially preventable complications have high costs. Significant interventions focusing on insertion of catheter and care and maintenance protocols have been helpful in reducing CLABSI rates. One component that remains a challenge is early/appropriate removal of central venous catheters (CVCs). The longer the central line remains in the patient, the increased chance of developing a CLABSI.
The study design is case-controlled with a control group composed of patients admitted in the previous year who received a CVC as part of the treatment plan and who did not received a midline catheter.The intervention phase of this study will involve placement of a standard of care, FDA approved midline catheter in patients that have a CVC. The Medical Intensive Care Unit (MICU) treating team will be consulted prior to approaching the patient. Written informed consent will be obtained from the patient or legal authorized representative prior to enrollment. The midline catheters will be inserted by the vascular access team within 24 hours of CVC insertion. Midline catheters will be assessed daily for function, phlebitis, and infection for up to 7 days. Mechanical complications or premature line failures will be tracked. Data specific to blood sampling will be collected daily. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. If the catheter failed or was removed prior to the follow-up assessment then the VAD failure time and the assessment of failure and reason for line removal will be obtained through chart review. For all failed catheters, re-insertion attempt data will be tracked through the medical record. If the patient is discharged prior to the time of follow-up assessment then the time of discharge will be documented and the VAD will be presumed functional until time of discharge unless otherwise noted in the chart. Some patients may leave the hospital with VAD in place for additional intravenous therapies. This information will be noted, but these patients will not receive follow-up assessments post-discharge for the research.If the patient has the midline longer than 7 days, the status of the line will be assessed via documentation in the electronic health record (EHR). The decision to remove the CVC is up to the treating physician.
Midline catheters will be assessed by research staff daily for usage. The medication administration record will be queried for all medications given through each catheter. Specifically, at the bedside we will assess whether the midline catheter is being used for any purpose. Of interest is the use of vesicants through the midline, medications that are generally given via central line or considered caustic to the vessel will be noted in both groups. Number of doses will be recorded.
Rates of symptomatic upper extremity superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates, as confirmed by sonography will be calculated. Radiology interpretations will be reviewed for findings consistent with catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT). This review will occur thirty days post patient discharge. Symptoms and rationale for imaging will be documented. If the patient is diagnosed with thrombophlebitis, the location of the thrombus will also be documented.
Infection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI). The IV team will assess all IV insertions sites for infection.
The control data was collected as a separate IRB-approved study. Additional data for control and intervention groups includes but is not limited to: patient medical record number (MRN), sex, age, admission diagnosis (top 2), discharge diagnosis (top 2), admission from Emergency center/floor/transfer, Charlson Comorbidity Index (CCI), date of central line placement, date of central line removal, location of central line, number of lumens, medications with particular attention to drips and vesicants, ICU length of stay, hospital length of stay, disposition from the ICU, CLABSI. Baseline variables will be evaluated for differences between cases and controls. Matching will be used to select the controls used for analysis.
- Conditions
- Vascular Access Complication, Central Line Complication, Central Line-Associated Infection, Superficial Vein Thrombosis, Deep Vein Thrombosis
- Being tested
- Midline catheter
- Keywords
- intravenous access, vascular access, IV survival, IV catheter complication, Central venous access, Central Line-associated Bloodstream Infection (CLABSI)
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline catheterDevice
Midline catheter placed in patients with existing standard of care CVC
| Study group | Role | What they receive |
|---|---|---|
| CVC and Midline Catheter | Experimental | Existing standard of care CVC. Midline catheter placed within 24 hours of CVC placement. Receives: Device: Midline catheter |
| CVC | No intervention | Standard of care CVC: case-matched controls using baseline data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVC hours
Number of hours from CVC insertion to CVC removal
Measured: at CVC removal, at any time up to 30 days
Secondary outcomes (4)
CLABSI
Number of participants with catheter-related lab-confirmed blood stream infection per Center of Disease Control (CDC) guidelines
Measured: 30 days
Upper extremity venous thrombosis
Number of participants with proven sonographic diagnosis of upper extremity deep vein thrombosis or superficial vein thrombosis
Measured: 30 days
Midline IV catheter survival
Number of participants with midline catheter survival, defined as ability to withdraw 3-5 mls blood or flush without resistance with 5 ml saline daily, until completion of therapy
Measured: 30 days
Midline Catheter Associated Phlebitis
Number of participants with each grade of phlebitis as assessed 0-5 Visual Phlebitis scale, where 0 indicates no phlebitis and 5 indicates advanced stages of thrombophlebitis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study startSep 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: No participants enrolled. Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective with historical case matched controls, Non-randomized, Single site
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Bahl, Corewell Health East
- Investigators
- Amit Bahl, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136561
- Sponsor's protocol ID
- 2019-235
- Status last verified
- Sep 2020
- First submitted
- 16 Oct 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategy to Encourage Early Removal of Central Venous Catheters
- ClinicalTrials.gov ID
- NCT04136561
- Acronym / sponsor ID
- 2019-235
- Conditions
- Vascular Access Complication, Central Line Complication, Central Line-Associated Infection, Superficial Vein Thrombosis, Deep Vein Thrombosis
- Keywords
- intravenous access, vascular access, IV survival, IV catheter complication, Central venous access, Central Line-associated Bloodstream Infection (CLABSI)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled. Unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Oct 2019 (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.
The goal of this study is to determine if early placement of a midline catheter in patients with a central venous catheter (CVC) will decrease the number of days the CVC is in place. Patients who are in the medical intensive care unit (MICU) and have a CVC may be approached to join the study. Those who meet study eligibility and provide written consent will be enrolled. The longer the CVC remains in place,the greater the chance of developing an infection or blood clot. Any IV line that is placed (CVC, midline, peripheral line) comes with the risk of infection or blood clots, although that risk is generally less with the midline and peripheral IV lines than a CVC. The treating team will make the decision when to remove the CVC. The timeline of removal will be compared to previous data collected on patients similar to the ones in this study. During their hospital stay, study patients will be monitored for how well the midline catheter is functioning as well as if they develop a catheter related blood clot or infection.
Detailed description
Central line-associated bloodstream infection (CLABSI) remains a serious problem contributing to patient morbidity and mortality. These potentially preventable complications have high costs. Significant interventions focusing on insertion of catheter and care and maintenance protocols have been helpful in reducing CLABSI rates. One component that remains a challenge is early/appropriate removal of central venous catheters (CVCs). The longer the central line remains in the patient, the increased chance of developing a CLABSI.
The study design is case-controlled with a control group composed of patients admitted in the previous year who received a CVC as part of the treatment plan and who did not received a midline catheter.The intervention phase of this study will involve placement of a standard of care, FDA approved midline catheter in patients that have a CVC. The Medical Intensive Care Unit (MICU) treating team will be consulted prior to approaching the patient. Written informed consent will be obtained from the patient or legal authorized representative prior to enrollment. The midline catheters will be inserted by the vascular access team within 24 hours of CVC insertion. Midline catheters will be assessed daily for function, phlebitis, and infection for up to 7 days. Mechanical complications or premature line failures will be tracked. Data specific to blood sampling will be collected daily. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. If the catheter failed or was removed prior to the follow-up assessment then the VAD failure time and the assessment of failure and reason for line removal will be obtained through chart review. For all failed catheters, re-insertion attempt data will be tracked through the medical record. If the patient is discharged prior to the time of follow-up assessment then the time of discharge will be documented and the VAD will be presumed functional until time of discharge unless otherwise noted in the chart. Some patients may leave the hospital with VAD in place for additional intravenous therapies. This information will be noted, but these patients will not receive follow-up assessments post-discharge for the research.If the patient has the midline longer than 7 days, the status of the line will be assessed via documentation in the electronic health record (EHR). The decision to remove the CVC is up to the treating physician.
Midline catheters will be assessed by research staff daily for usage. The medication administration record will be queried for all medications given through each catheter. Specifically, at the bedside we will assess whether the midline catheter is being used for any purpose. Of interest is the use of vesicants through the midline, medications that are generally given via central line or considered caustic to the vessel will be noted in both groups. Number of doses will be recorded.
Rates of symptomatic upper extremity superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates, as confirmed by sonography will be calculated. Radiology interpretations will be reviewed for findings consistent with catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT). This review will occur thirty days post patient discharge. Symptoms and rationale for imaging will be documented. If the patient is diagnosed with thrombophlebitis, the location of the thrombus will also be documented.
Infection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI). The IV team will assess all IV insertions sites for infection.
The control data was collected as a separate IRB-approved study. Additional data for control and intervention groups includes but is not limited to: patient medical record number (MRN), sex, age, admission diagnosis (top 2), discharge diagnosis (top 2), admission from Emergency center/floor/transfer, Charlson Comorbidity Index (CCI), date of central line placement, date of central line removal, location of central line, number of lumens, medications with particular attention to drips and vesicants, ICU length of stay, hospital length of stay, disposition from the ICU, CLABSI. Baseline variables will be evaluated for differences between cases and controls. Matching will be used to select the controls used for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective with historical case matched controls, Non-randomized, Single site
| Arm | Type | Receives |
|---|---|---|
| CVC and Midline Catheter | Experimental | Device: Midline catheterExisting standard of care CVC. Midline catheter placed within 24 hours of CVC placement. |
| CVC | No intervention | –Standard of care CVC: case-matched controls using baseline data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients 18 years of age or older admitted to the MICU at Beaumont Hospital- Royal Oak who require a CVC Midline placement by the vascular access team within 24 hours of CVC placement
Key exclusion criteria (4 listed)
- Patients not admitted to MICU
- Patients < 18 years of age
- Patients identified to require a PICC for extended duration of therapy
- Patients with midline catheters, pre-existing ports, dialysis catheters (Quinton), or other vascular access already inserted within the first 24 hours of CVC insertion (peripheral IV catheters are allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midline catheterMidline catheter placed in patients with existing standard of care CVC | Device | CVC and Midline Catheter |
Primary outcome
CVC hours
Time frame: at CVC removal, at any time up to 30 days
Number of hours from CVC insertion to CVC removal
4 secondary outcomes
CLABSI
Time frame: 30 days
Upper extremity venous thrombosis
Time frame: 30 days
Midline IV catheter survival
Time frame: 30 days
Midline Catheter Associated Phlebitis
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Amit Bahl, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline catheter in people with Vascular Access Complication and Central Line Complication, run by Corewell Health East 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Sep 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
CVC hours (time frame: at CVC removal, at any time up to 30 days). 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 9 Sep 2020.