NCT03523260

Brief Summary

The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

6.4 years

First QC Date

February 7, 2018

Last Update Submit

May 6, 2021

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    1 month complication rate of left internal jugular vein dialysis catheters

    1 month

Secondary Outcomes (5)

  • Catheter dysfunction

    1 months

  • Catheter dysfunction

    3 months

  • Catheter dysfunction

    6 months

  • Complication rate

    3 months

  • Complication rate

    6 months

Study Arms (3)

Tunneled dialysis Split-tip catheter

ACTIVE COMPARATOR

High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.

Tunneled dialysis Step-tip catheter

ACTIVE COMPARATOR

High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.

Tunneled dialysis Symmetric tip catheter

ACTIVE COMPARATOR

High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.

Interventions

Tunneled dialysis catheter placement.DEVICE

Placement of high-flow tunneled catheter for hemodialysis

Tunneled dialysis Split-tip catheterTunneled dialysis Step-tip catheterTunneled dialysis Symmetric tip catheter

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide a written informed consent
  • years or older
  • Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
  • Patent left internal jugular vein.
  • Able to read and understand English.

You may not qualify if:

  • Previous enrollment in this trial
  • Patients unable or unwilling to provide informed consent
  • Prisoners or incarcerated individuals
  • Women who are pregnant
  • Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Akabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Radiology

Study Record Dates

First Submitted

February 7, 2018

First Posted

May 14, 2018

Study Start

August 27, 2013

Primary Completion

January 22, 2020

Study Completion

January 22, 2020

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)