NCT01649102

Brief Summary

The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic hemodialysis patients. The design of the catheter may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation and hence the efficiency of dialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

July 18, 2012

Last Update Submit

January 13, 2015

Conditions

Chronic HemodialysisCatheter Related Bloodstream InfectionMechanical Catheter Dysfunction

Keywords

Chronic hemodialysisTunneled cuffed catheterCatheter-related bloodstream infectionMechanical catheter dysfunctionimpact of catheter design on outcome

Outcome Measures

Primary Outcomes (1)

  • overall catheter survival rate

    3 years

Secondary Outcomes (1)

  • Mechanical catheter dysfunction: number of dialysis sessions requiring urokinase administration per 1000 catheter days; number of catheter removals for mechanical obstruction

    3 years

Other Outcomes (1)

  • Dialysis efficiency: Kt/V; mean achieved blood flow rate per dialysis session

    3 years

Study Arms (2)

Palindroom catheter

EXPERIMENTAL

Insertion of Palindroom catheter

Device: Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)

Hemoglide Bard Catheter

EXPERIMENTAL

Insertion of Hemoglide Bard Catheter

Device: Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)

Interventions

Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)DEVICE

A tunneled cuffed catheter is inserted, randomization between: * Palindroom * Hemoglide Bard

Hemoglide Bard CatheterPalindroom catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnancy or breast-feeding
  • Life-expectance of \< 6 months due to major co-morbid conditions
  • Inability to provide informed consent
  • Occlusion or inaccessibility of the right internal jugular vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ ST JAn Brugge Oostende AV

Bruges, B-8000, Belgium

Location

Study Officials

  • An S De Vriese, M.D., Ph.D.

    AZ ST JAN Brugge Oostende AV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph. D.

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 25, 2012

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

BE(1)