Pharmakokinetik von lipid-formuliertem Amphotericin B unter Albumindialyse(Pharmacokinetics of lipid-formulated amphotericin B during albumin dialysis) - Amphotericin B in Albumin dialysis
Phase 1
- Conditions
- Plasma concentrations of lipidformulated amphotericin B will be measured in patients requiring treatment with lipid-formulated amphotericin B for systemic fungal infection (proven or suspected) and impaired renal function as well as albumin dialysis for cholestatic liver failure.
- Registration Number
- EUCTR2005-003406-28-AT
- Lead Sponsor
- Medical University, Dpt. Internal Medicin, Division of General Inteal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Indication for treatment with lipid-formulated amphotericin B
Indication for albumin dialysis
Need for arterial/venous line
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Age below 18 years
lacking indication / contraindicatio for lipidfromulate amphotericin B
lacking indication / contraindication for albumin dialysis
lacking consent
pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine pharmacokinetics of lipid-formulated amphotericin B in patients undergoing albumindialysis;Secondary Objective: To provide dose recommendations for lipid-formulated amphotericin B administered to patients on albumin dialysis.<br><br>To detect relvan pharmcokinetic differences between the threee amphotericin B lipid-formulations when administered to patients on albumin dialysis.;Primary end point(s): pharmacokinetics of lipidformulated amphotericin B: Cmax, Cmin, AUC, Kel, T 1/2, Vd, Clearance
- Secondary Outcome Measures
Name Time Method