NCT00621114

Brief Summary

The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

January 31, 2008

Last Update Submit

March 11, 2025

Conditions

Hemodialysis

Keywords

Dialysis, ExtracorporealDialysis, RenalExtracorporeal DialysisHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Bacterial colonisation of the catheter surface

    after explantation

Secondary Outcomes (4)

  • venous and arterial pressure

    during dialysis

  • catheter dwell time

    at explantation

  • exit site appearance

    at routine catheter care

  • blood parameters

    during dialysis

Study Arms (2)

1

ACTIVE COMPARATOR

Patients in group 1 will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891).

Device: GamCath® central venous catheter

2

EXPERIMENTAL

Patients in group 2 will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671).

Device: GamCath Dolphin® Protect central venous catheter

Interventions

GamCath® central venous catheterDEVICE

Choice of central venous catheter type

Also known as: GamCath® catheter
1
GamCath Dolphin® Protect central venous catheterDEVICE

Choice of central venous catheter type

Also known as: GamCath Dolphin® Protect
2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • central venous catheter placement
  • Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
  • Anticipated duration of dialysis therapy less than or equal to 30 days
  • Age between 18 and 85 years
  • Written informed consent

You may not qualify if:

  • Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Study Officials

  • Teut Risler, Prof. Dr.

    Universitaetsklinikum Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 22, 2008

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DE(1)