The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
- Registration Number
- NCT01008631
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- healthy volunteer or patient with renal failure
Exclusion Criteria
- pregnancy
- withdrawal of consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dialysis Sodium thiosulfate Two doses of sodium thiosulfate healthy volunteer Sodium thiosulfate One dose of sodium thiosulfate
- Primary Outcome Measures
Name Time Method Elimination half life in dependence of the degree of renal failure 0, 15, 30, 60, 180 minutes and 24 hours after application
- Secondary Outcome Measures
Name Time Method Changes in acid-base parameter after application of sodium thiosulfate 0, 15, 30, 60, 180 minutes and 24 hours after application
Trial Locations
- Locations (1)
Department of Nephrology and Hypertension, University of Berne
🇨ðŸ‡Berne, Switzerland