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Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GamCath® central venous catheter
GamCath Dolphin® Protect central venous catheter
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Insufficiency focused on measuring Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • central venous catheter placement
  • Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
  • Age over 18 years
  • Written informed consent
  • Needed catheter length 15 cm or 20 cm

Exclusion Criteria:

  • Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
  • Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
  • Bacteremia with a former catheter within 10 days prior to catheter implantation
  • Known pregnancy
  • Lactation
  • Participation in another clinical study during the preceding 30 days

Sites / Locations

  • St. Joseph-Krankenhaus Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bacterial colonisation of the catheter surface

Secondary Outcome Measures

Surface deposits of thrombogenic activity
Catheter survival
Exit site appearance
Blood parameters

Full Information

First Posted
January 31, 2008
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00621712
Brief Title
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
Official Title
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.
Detailed Description
The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation. In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed. Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections. The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891).
Arm Title
B
Arm Type
Experimental
Arm Description
Patients in group B will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671).
Intervention Type
Device
Intervention Name(s)
GamCath® central venous catheter
Other Intervention Name(s)
GamCath® catheter, No. CE 76891
Intervention Description
choice of catheter type
Intervention Type
Device
Intervention Name(s)
GamCath Dolphin® Protect central venous catheter
Other Intervention Name(s)
GamCath Dolphin® Protect, No.CE 90671
Intervention Description
choice of catheter type
Primary Outcome Measure Information:
Title
Bacterial colonisation of the catheter surface
Time Frame
at explantation
Secondary Outcome Measure Information:
Title
Surface deposits of thrombogenic activity
Time Frame
at explantation
Title
Catheter survival
Time Frame
at explantation
Title
Exit site appearance
Time Frame
at routine catheter care
Title
Blood parameters
Time Frame
during dialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: central venous catheter placement Need for extracorporeal renal replacement therapy (acute and chronic renal failure) Age over 18 years Written informed consent Needed catheter length 15 cm or 20 cm Exclusion Criteria: Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation Bacteremia with a former catheter within 10 days prior to catheter implantation Known pregnancy Lactation Participation in another clinical study during the preceding 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane M Erley, Prof. Dr.
Organizational Affiliation
St. Joseph-Krankenhaus Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph-Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
12101
Country
Germany

12. IPD Sharing Statement

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Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

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