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Sponsored by: |
Ramathibodi Hospital |
---|---|
Information provided by: | Ramathibodi Hospital |
ClinicalTrials.gov Identifier: | NCT00720772 |
The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.
Condition | Intervention | Phase |
---|---|---|
Coronary Calcification Vascular Calcification |
Drug: 25% intravenous (IV) sodium thiosulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis |
Estimated Enrollment: | 50 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: 25% intravenous (IV) sodium thiosulfate
100 ml IV drip twice/week post hemodialysis
|
B: No Intervention |
Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sinee Disthabanchong, M.D | +6622011116 | tesdb@mahidol.ac.th |
Contact: Surawat Adirekkiat, M.D. | +6622101116 | surawat_adi@hotmail.com |
Thailand, Bangkok | |
Ramathibodi Hospital | Recruiting |
Phayathai, Bangkok, Thailand, 10400 | |
Contact: Sinee Disthabanchong, M.D. +6622011116 tesdb@mahidol.ac.th | |
Principal Investigator: Sinee Disthabanchong, M.D. |
Principal Investigator: | Sinee Disthabanchong, M.D. | Ramathibodi Hospital, Mahidol University |
Responsible Party: | Ramathibodi Hospital. Mahidol University ( Sinee Disthabanchong, M.D. ) |
Study ID Numbers: | ID 02-51-31 |
Study First Received: | July 21, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00720772 |
Health Authority: | Thailand: Ethical Committee |
coronary calcification vascular calcification sodium thiosulfate |
Calcinosis Metabolic Diseases Sodium thiosulfate Metabolic disorder |
Calcium Metabolism Disorders Anti-Infective Agents Anti-Bacterial Agents Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Chelating Agents Antitubercular Agents Protective Agents Pharmacologic Actions Antidotes |