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

Completed

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

• Registration Number: ISRCTN81821807
• Lead Sponsor: Gambro Corporate Research (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety (early removal due to catheter failure)<br>2. Handling (implantation, removal)<br>3. Efficacy (hemodialysis blood flow rate, pressure)

Secondary Outcome Measures

Name	Time	Method
1. Frequency of exit site and catheter-related bloodstream infections<br>2. Bacterial growth on the catheter<br>3. Inflammatory and coagulation parameters in plasma