Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties - Full Text View

Sponsored by:	Gambro Dialysatoren GmbH
Information provided by:	Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:	NCT00621712

Purpose

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.

Condition	Intervention
Hemodialysis	Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education

Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:

Bacterial colonisation of the catheter surface [ Time Frame: at explantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Surface deposits of thrombogenic activity [ Time Frame: at explantation ] [ Designated as safety issue: No ]
Catheter survival [ Time Frame: at explantation ] [ Designated as safety issue: No ]
Exit site appearance [ Time Frame: at routine catheter care ] [ Designated as safety issue: No ]
Blood parameters [ Time Frame: during dialysis ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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).	Device: GamCath® central venous catheter choice of catheter type
B: Experimental 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).	Device: GamCath Dolphin® Protect central venous catheter choice of catheter type

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621712

Contacts

Contact: Heike B Lebsanft, Dr.	+49 (0) 7471 17 -0 ext 2008	Heike.Lebsanft@Gambro.com
Contact: Werner Beck, Dr.	+49 (0) 7471 17 -0 ext 1259	Werner.Beck@Gambro.com

Locations

Germany
St. Joseph-Krankenhaus Berlin	Recruiting
Berlin, Germany, 12101
Contact: Christiane M Erley, Prof. Dr. ++49 30-7882- 0 ext -2379 Christiane.Erley@sjk.de
Contact: Birgit D Bader, Dr. med. ++49 30- 7882 - 0 ext -2168 Birgit.Bader@sjk.de
Principal Investigator: Christiane M Erley, Prof. Dr.
Sub-Investigator: Birgit D Bader, Dr. med.

Sponsors and Collaborators

Gambro Dialysatoren GmbH

Investigators

Principal Investigator:

Christiane M Erley, Prof. Dr.

St. Joseph-Krankenhaus Berlin

More Information

No publications provided

Responsible Party:	Gambro Dialysatoren GmbH ( Manager Clinical Research )
Study ID Numbers:	Study No 2007_MBR_001, ISRCTN93939200
Study First Received:	January 31, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00621712 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:

Renal Dialysis
Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009