Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Phase 2CompletedNCT00720772

Ramathibodi Hospital50 enrolled

Overview

The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Calcification Vascular Calcification

Interventions

25% intravenous (IV) sodium thiosulfateDRUG

50 ml IV drip twice/week post hemodialysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CAC score \> 300 * Life expectancy \> 6 months * Dialysis vintage \> 6 months Exclusion Criteria: * Non-compliance to hemodialysis

Locations (1)

Ramathibodi Hospital

Phayathai, Bangkok, Thailand

Outcomes

Primary Outcomes

CAC score

Time frame: 6 months

Secondary Outcomes

Bone mineral density, calcium removal

Time frame: 6 months, 1 and 2 months

Data from ClinicalTrials.gov

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