Renal disease Urological and Genital Diseases Renal disease
Conditions
Interventions
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 d
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 arter
Sponsors
Gambro Dialysatoren GmbH (Germany)
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection 2. Known pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed