Condition category
Urological and Genital Diseases
Date applied
30/08/2007
Date assigned
19/09/2007
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dr. med. Teut Risler

ORCID ID

Contact details

Dr. med. Bjorn Friedrich
Universitatsklinikum Tübingen
Medizinische Klinik
Abteilung IV
Sektion fur Nieren- und Hochdruckkrankheiten
Otfried-Muller-Strasse 10
Tubingen
72076
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00621114

Protocol/serial number

Study No 2007_MBR_003

Study information

Scientific title

Acronym

Study hypothesis

The clinical study aims at providing further 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 but with identical design.

Ethics approval

Approval was granted by the local medical ethics committee (Ethikkommission der Medizinischen Fakultat der Eberhard-Karls-Universitat und am Universitatsklinikum Tubingen) on 25th July 2007 (ref:154/2007MPG1).

Study design

Prospective, randomised, single-centre, clinical study with 2 parallel patient groups (A and B) after prior sub-group stratification.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Renal disease

Intervention

Commercially available catheters will be used; the design will not be blinded. Catheters will be placed according to a defined protocol. The investigator selects the appropriate catheter length for each patient.

Type X: Standard double lumen catheter without coating: commercially available CE certified GamCath® catheter (Gambro Kathetertechnik Hechingen, Germany), Product codes: GDHK-1315J (outer diameter 13 French, length 15 cm, curved extension lines), GDHK-1320J (outer diameter 13 French, length 20 cm, curved extension lines)

Type Y: Double lumen catheter with bismuth-containing coating: commercially available, CE certified GamCath Dolphin® Protect catheter (Gambro Kathetertechnik Hechingen, Germany) with similar design and measures as the standard catheter, but with antibacterial coating, Product codes: MC-GDHK-1315J (outer diameter 13 French, length 15 cm, curved extension lines), MC-GDHK-1320J (outer diameter 13 French, length 20 cm, curved extension lines).

Catheters will be removed based on clinical indication; therefore there is no exact duration of treatment. There will be no follow-up blood investigations for the patient. The maximal observation period is 29 days.

Used catheters and arterial and venous rinsing fluids will be analysed for bacterial colonisation. A cut-off 100 CFU/mL will be defined as positive. Further characterisation of bacteria will be performed with focus on genetic variations of bacteria that might be attributed to inhibition or resistance mechanisms on the catheters.

Citrate plasma and lock solution samples will be analysed for bismuth concentrations by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Routine clinical laboratory data will be analysed according to local clinical laboratory routine.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Bacterial colonisation of the catheter surface, analysed after removal of the catheter. A cut-off 100 CFU/mL will be defined as positive
2. Bismuth content in plasma and lock solution will be analysed before catheter placement, once weekly pre-dialysis and once at explantation

Secondary outcome measures

1. Catheter patency (indirect measure: venous and arterial pressure differences)
2. Catheter dwell time
3. Exit site appearance
4. Blood parameters

Secondary outcome measured will be documented at routine sampling.

Overall trial start date

08/08/2007

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
2. Anticipated duration of dialysis therapy less than or equal to 30 days
3. Age between 18 and 85 years
4. Written informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

69 patients with need for renal replacement therapy will be included in the study in a first approach.

Participant exclusion criteria

1. Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
2. Known pregnancy

Recruitment start date

08/08/2007

Recruitment end date

31/03/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Dr. med. Bjorn Friedrich
Tubingen
72076
Germany

Sponsor information

Organisation

Gambro Dialysatoren GmbH (Germany)

Sponsor details

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Sponsor type

Industry

Website

http://www.gambro.com/Portal.aspx?id=8644

Funders

Funder type

Industry

Funder name

Gambro Dialysatoren GmbH (Germany) - grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) - Activities are part of the BMBF BioProfile project "Antibakterielle und biofunktionale Oberflachen fur extrakorporale sowie zelltherapeutische Verfahren" (ref: Forderkennzeichen 0313648)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes