Clinical assessment of a new catheter surface coating with antimicrobial properties: safety - handling - efficacy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81821807

Enrollment

100

Registered

2006-03-24

Start date

2004-05-24

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease patients with need for a temporary hemodialysis catheter Urological and Genital Diseases Renal disease

Interventions

Comparison of standard temporary hemodialysis catheter with a new catheter with antibacterial/anti-biofilm coating

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Need for renal replacement therapy 2. Age =18 years 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Known acute hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 2. Age >75 years 3. Any infection associated wtih one or more positive blood cultures within 10 days prior to planned implantation 4. Any bacteremia associated with a previous catheter 5. Known pregnancy 6. Hospitalisation for more than 14 days 7. Respiratory assist 8. Use of antibiotics 9. Participation in another study during the preceding 30 days

Design outcomes

Primary

Measure	Time frame
1. Safety (early removal due to catheter failure) 2. Handling (implantation, removal) 3. Efficacy (hemodialysis blood flow rate, pressure)	—

Secondary

Measure	Time frame
1. Frequency of exit site and catheter-related bloodstream infections 2. Bacterial growth on the catheter 3. Inflammatory and coagulation parameters in plasma	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026