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Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

NCT ID: NCT00720772

Last Updated: 2009-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Calcification Vascular Calcification

Keywords

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coronary calcification vascular calcification sodium thiosulfate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

25% intravenous (IV) sodium thiosulfate

Intervention Type DRUG

50 ml IV drip twice/week post hemodialysis

B

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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25% intravenous (IV) sodium thiosulfate

50 ml IV drip twice/week post hemodialysis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CAC score \> 300
* Life expectancy \> 6 months
* Dialysis vintage \> 6 months

Exclusion Criteria

* Non-compliance to hemodialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ramathibodi Hospital. Mahidol University

Principal Investigators

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Sinee Disthabanchong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Locations

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Ramathibodi Hospital

Phayathai, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, Wang Y, Chung J, Emerick A, Greaser L, Elashoff RM, Salusky IB. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000 May 18;342(20):1478-83. doi: 10.1056/NEJM200005183422003.

Reference Type BACKGROUND
PMID: 10816185 (View on PubMed)

London GM, Guerin AP, Marchais SJ, Metivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003 Sep;18(9):1731-40. doi: 10.1093/ndt/gfg414.

Reference Type BACKGROUND
PMID: 12937218 (View on PubMed)

Matsuoka M, Iseki K, Tamashiro M, Fujimoto N, Higa N, Touma T, Takishita S. Impact of high coronary artery calcification score (CACS) on survival in patients on chronic hemodialysis. Clin Exp Nephrol. 2004 Mar;8(1):54-8. doi: 10.1007/s10157-003-0260-0.

Reference Type BACKGROUND
PMID: 15067517 (View on PubMed)

Cicone JS, Petronis JB, Embert CD, Spector DA. Successful treatment of calciphylaxis with intravenous sodium thiosulfate. Am J Kidney Dis. 2004 Jun;43(6):1104-8. doi: 10.1053/j.ajkd.2004.03.018.

Reference Type BACKGROUND
PMID: 15168392 (View on PubMed)

Other Identifiers

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ID 02-51-31

Identifier Type: -

Identifier Source: org_study_id