Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter

Completed

• Conditions: Pain; Dialysis Catheter
• Interventions: Device: CentrosFLO Long Term Hemodialysis Catheter

• Registration Number: NCT02349308
• Lead Sponsor: Merit Medical Systems, Inc.

Brief Summary

The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement.

Detailed Description

The CentrosFLO™ Tunneled Dialysis Catheter is a 15F dual-lumen, double-D shaped catheter similar to other "split tip" catheters in the market: outflow ("arterial") and return ("venous") lumens that separate, a subcutaneous Dacron® cuff, extension sets with clamps and caps, and construction from Carbothane® material. The CentrosFLO™ catheter contains two small pressure-relief holes near the tips.

The main difference of the CentrosFLO catheter is in the design of the tip. Current "split tip" catheters have two free ends that diverge, but are each essentially straight segments. In the CentrosFLO catheter the arterial lumen bends in an arc back towards the venous lumen, and the venous lumen bends towards the arterial lumen. As a result, the catheter has two curved surfaces that will rest against the vena cava wall to automatically "center" the catheter within the vein. The contact points of the catheter against the vena cava wall should be smaller and more disperse than with current straight-tip or split catheters. The following drawing demonstrates the design of the catheter, showing the current recommendation that the arterial port always be to the left.

The goal of the study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement. The investigators plan to enroll 10 patients in the study.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-09-23
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein
• The patients may have had a prior tunneled catheter for dialysis in the right IJ site.
• Patients will be expected to need use of the catheter for more than 45 days

Exclusion Criteria

• Patients in whom the catheter is planned to be placed into the same site as an existing catheter, by over-the-wire catheter exchange
• Patients unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CentrosFLO Long Term Hemodialysis Catheter	CentrosFLO Long Term Hemodialysis Catheter	Schedule placement of catheter. Arterial tip of the catheter should be placed at or just above the junction of the right atrium and superior vena cava, with the arterial lumen on the left side of the catheter. The venous limb will extend into the right atrium. Catheter will be locked with the usual heparin lock solution for a newly placed catheter (at least 500 units per lumen). Fluoroscopic images will document tip position.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months	1.5 years	Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: Incidence of patency failure defined as blood flow rate below 300 mL/min or removal of catheter for failure of flow at any time during the study.	1.5 years	Incidence of patency failure defined as blood flow rate below 300 mL/min or removal of catheter for failure of flow at any time during the study.

Trial Locations

Locations (7)

Angiocare; 🇺🇸 Tucson, Arizona, United States

Sierra Nephrology; 🇺🇸 Reno, Nevada, United States

IU School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Olive View- UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States

OSU Medical Center; 🇺🇸 Columbus, Ohio, United States

IU Health Arnett; 🇺🇸 Lafayette, Indiana, United States