Renal disease Urological and Genital Diseases Renal disease
Conditions
Interventions
A prospective, randomised, single-centre, double-blind clinical study with two parallel patient groups (A and B) will be conducted. All patients will be examined for nasal Methicillin Resistant Staphy
Sponsors
Gambro Dialysatoren GmbH (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Need for extracorporeal renal replacement therapy (acute and chronic renal failure) 2. Age over 18 years 3. Written informed consent 4. Needed catheter length 15 cm or 20 cm
Exclusion criteria
Exclusion criteria: 1. Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) 2. Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation 3. Bacteremia with a former catheter within 10 days prior to catheter implantation 4. Known pregnancy 5. Lactation 6. Participation in another clinical study during the preceding 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial colonisation of the catheter surface. The time points of catheter analysis cannot be given exactly as these analyses are done after removal of the catheter and removal is determined by medical indication not influenced by the study protocol. The other sampling points and number of analyses are also depending on the individual patient?s treatment regimen. The maximal observation period is 29 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surface deposits of thrombogenic activity 2. Catheter survival 3. Exit site appearance 4. Blood parameters: 4.1. Blood counts: blood analysis once weekly at start of dialysis sessions 4.2. Coagulation parameters PTT, AT III and PCT: blood analysis once weekly at start of dialysis sessions 4.3. CRP and fibrinogen: blood analysis at start of each dialysis session 4.4. Bismuth analysis in plasma before implantation of the catheter, at start and end of the first dialysis session, once weekly at start of the following dialysis sessions and at explantation of the catheter 4.5. Bismuth analysis from the lock-solution before start of each dialysis treatment The time points of catheter analysis cannot be given exactly as these analyses are done after removal of the catheter and removal is determined by medical indication not influenced by the study protocol. The other sampling points and number of analyses are also depending on the individual patient?s treatment regimen. The maximal observation period is 29 days. | — |
Countries
Germany
Outcome results
None listed