The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers

October 12, 2011 updated by: University Hospital Inselspital, Berne

The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy

The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3010
        • Department of Nephrology and Hypertension, University of Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteer or patient with renal failure

Exclusion Criteria:

  • pregnancy
  • withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dialysis
Two doses of sodium thiosulfate
Drug: Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other Names:
  • Na2S2O3
Experimental: healthy volunteer
One dose of sodium thiosulfate
Drug: Sodium thiosulfate
6g of Sodium Thiosulfate are applicated in a short infusion over a time of 5 min
Other Names:
  • Na2S2O3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elimination half life in dependence of the degree of renal failure
Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application
0, 15, 30, 60, 180 minutes and 24 hours after application

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in acid-base parameter after application of sodium thiosulfate
Time Frame: 0, 15, 30, 60, 180 minutes and 24 hours after application
0, 15, 30, 60, 180 minutes and 24 hours after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Stefan Farese, MD, University of Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uehlinger-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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