Catheter Infection Clinical Trial in Royal Oak MI
NCT03725293
| Interventional
This study has recruited 212 Participants
Peripherally inserted central catheters (PICCs) are central catheters that are placed via
peripheral vein under ultrasound guidance and may be used for patients with difficult venous
access for long-term central or peripheral infusion therapies as well as central venous
pressure monitoring in a critical care setting. Although PICCs provide a great option for
some patients, these catheters have known complications including catheter-related
bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high
cost. Midline catheters represent a potentially attractive alternative to PICCs for
peripheral infusions. As midlines have increased in popularity and new midlines have been
introduced into the market, it is necessary to better understand complication profiles of
various midline catheters, as it is likely that all catheters are not created equal.
Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some
midline catheters are coated to provide protection against catheter-related venous thrombosis
and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters
need further validation in human subjects.
Details for the study
Brief Title
Midlines and Thrombophlebitis
Official Title
Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis
Brief Summary
Peripherally inserted central catheters (PICCs) are central catheters that are placed via
<br /> peripheral vein under ultrasound guidance and may be used for patients with difficult venous
<br /> access for long-term central or peripheral infusion therapies as well as central venous
<br /> pressure monitoring in a critical care setting. Although PICCs provide a great option for
<br /> some patients, these catheters have known complications including catheter-related
<br /> bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high
<br /> cost. Midline catheters represent a potentially attractive alternative to PICCs for
<br /> peripheral infusions. As midlines have increased in popularity and new midlines have been
<br /> introduced into the market, it is necessary to better understand complication profiles of
<br /> various midline catheters, as it is likely that all catheters are not created equal.
<br /> Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some
<br /> midline catheters are coated to provide protection against catheter-related venous thrombosis
<br /> and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters
<br /> need further validation in human subjects.
Detailed Description
Study Design
The investigators propose a prospective single-site, parallel, two-arm, randomized
investigation to assess catheter-related symptomatic upper extremity venous thrombosis
(CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen
midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.
Research staff of Beaumont Health Institute will allocate two midline catheters to eligible
participants according to a pre-generated randomized list at a 1:1 ratio in block
randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline
catheters. Participant enrollment will take place from November 2018 until recruitment of 250
participants, 125 in each group, is complete. Demographic and health-related information will
be obtained from electronic medical records during enrolled period at William Beaumont
Hospital.
Practitioner Participation/Training
Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus
are eligible to place catheters for this study. All investigators are credentialed in placing
PICCs and midlines by institutional policy and have greater than one year of experience in
these procedures.
Initial Assessment
Post-cannulation and post securement, functionality is confirmed with blood sampling (10 cc)
and flush without resistance.
The research team also will document practitioner details, the vascular access device (VAD)
used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein
that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An
attempt is defined as each time the needle punctures the skin. Data will be collected from
the electronic medical record and includes: age, gender, body mass index (BMI), vital signs,
relevant past medical history. Indication for catheter placement will also be recorded.
Follow-up Assessment
Investigators will perform a follow-up assessment on all catheters within 24 hours of
insertion and then daily for the life of the VAD. At each follow-up interval, the researcher
will document the time of evaluation and assessment of functionality as well as review the
patient chart for signs and symptoms of catheter-related bloodstream infection. 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. For all failed catheters, re-insertion
attempt data will be tracked through the medical record.
Superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated
based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology
interpretations will be reviewed for findings consistent with CR-UEVT.
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 medication administration record will be queried for all medications given through each
catheter.
Treatments and/or Procedures
Angiodynamics bio flo midline catheter
Placement of Angiodynamics BioFlo Midline Catheter.
Teleflex arrowg ard blue advanced midline catheter
Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Upper Extremity CR-UEVT
Number of participants with proven sonographic diagnosis of DVT and/or SVT
Secondary
Line Related Infection
Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines
Study Criteria
Inclusion Criteria:
- All inpatients 18 years of age and older
- Inpatients that require midline catheter placement by the bedside vascular access team
Exclusion Criteria:
- Do not meet inclusion criteria
- Multiple lumens required
- Alternative diameter of catheter used
- If already enrolled once prior
- Withdraw voluntarily from the study
- Actively (within 24 hours) taking a therapeutic dose of an anticoagulant (heparin, low
molecular weight heparin, enoxaparin, rivaroxaban, apixaban, dabigatran, edoxaban,
warfarin, arixtra, factor Xa inhibitors)
- Receiving a midline catheter for anticoagulant therapy