Renal Failure
Conditions
Keywords
renal failure, sodium Thiosulfate, pharmakokinetic
Brief summary
The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.
Detailed description
Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session. In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.
Interventions
DRUGSodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteer or patient with renal failure
Exclusion criteria
* pregnancy * withdrawal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination half life in dependence of the degree of renal failure | 0, 15, 30, 60, 180 minutes and 24 hours after application |
Secondary
| Measure | Time frame |
|---|---|
| Changes in acid-base parameter after application of sodium thiosulfate | 0, 15, 30, 60, 180 minutes and 24 hours after application |
Countries
Switzerland
Outcome results
None listed