Effect Of Sodium Thiosulfate On Arterial Stiffness in End-Stage Renal Disease Patients Undergoing Chronic Hemodialysis

Phase 3

Completed

• Conditions: ESRD patients undergoing chronic HDPresence of arterial stiffness measured by cfPWV and CAVI methodVascular calcificationInflammation in ESRD patients undergoing chronic HD; ESRD; chronic hemodialysis; arterial stiffness; vascular calcification; sodium thiosulfate; cPWV; CAVI; CT coronary calcium score

• Registration Number: TCTR20160814001
• Lead Sponsor: Jongkolnee Nidhi foundation Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-14
• Study Completion: 2017-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Age older than 18 years old
2.Dialysis vintage at least 6 months’ duration
3.Hemodialysis frequency 2 or 3 times per week
4.Presence of increased arterial stiffness measured by cfPWV (cfPWV>=10 m/s)
5.Informed consent
6.Can follow the research methodology and follow up regularly

Exclusion Criteria

1.Life expectancy less than 6 months
2.Missing a dialysis session more than twice per month
3.Active malignancy or infection
4.Known pregnancy
5.Recently use of oral or IV corticosteroid therapy within 1 month (dose more than 5 mg of prednisolone or equivalent)
6.Allergy or known sensitivity to sodium thiosulfate
7.Intact PTH more than 9 times of UNL in previous 3 months ( using 2nd generation intact PTH more than 585 pg/ml)
8.Abnormal limb that cannot be measured by cfPWV eg. above or below knee amputation, severe PAD etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial stiffness 24 weeks carotid-femoral pulse wave velocity (cfPWV)

Secondary Outcome Measures

Name	Time	Method
Vascular calcification 24 weeks CT Coronary Artery Calcium score,Inflammatory marker 24 weeks high-sensitivity CRP (hsCRP),Arterial stiffness (BP independent method) 24 weeks Cardio-Ankle Vascular Index (CAVI),Arterial siffness 48 weeks Carotid-femoral pulse wave velocity (cfPWV)