Vascular Access Complication, Vascular Access Related Infection
Conditions
Brief summary
A prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. All subjects will receive PICC access using the Arrow PICC with Chloragard Technology.
Interventions
DEVICEArrow PICC with Chloragard Technology
chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
Sponsors
Arrow International
Teleflex
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater (note: maximum study period is 90 days) * Ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of PICC management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary * Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study
Exclusion criteria
* Previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter * History or diagnosis of peripheral or central vein stenosis (on proposed insertion side) * History or diagnosis of veno-occlusive disease * History or diagnosis of superior vena cava syndrome * Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease * Previous enrollment in this study * Currently pregnant or breast feeding * Previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent * Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis * Medical, social, and/or psychological problems precluding subject from study participation * Stage 2, 3 or 4 chronic kidney disease or serum creatinine \> 3 mg/dl or Glomerular Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a nephrologist for participation * Known allergy or sensitivity to chlorhexidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT) | within maximum 90 days dwell |
| Incidence of catheter occlusion | within maximum 90 days dwell |
| Incidence of catheter-related bloodstream infections | within maximum 90 days dwell |
Countries
United States
Contacts
Primary ContactTatiana Puga
Backup ContactThomas Philbeck, PhD
Outcome results
None listed