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

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20160814001
• Date of registration: 14/08/2016
• Prospective Registration: No
• Primary sponsor: Jongkolnee Nidhi foundation Fund
• Public title: Effect Of Sodium Thiosulfate On Arterial Stiffness in End-Stage Renal Disease Patients Undergoing Chronic Hemodialysis
• Scientific title: Effect Of Sodium Thiosulfate On Arterial Stiffness in End-Stage Renal Disease Patients Undergoing Chronic Hemodialysis
• Date of first enrolment: 01/07/2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160814001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Donlawat Saengpanit
• Affiliation: King Chulalongkorn Memorial Hospital

• Name: Donlawat Saengpanit
• Affiliation: King Chulalongkorn Memorial Hospital

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 0 N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

ESRD patients undergoing chronic HD Presence of arterial stiffness measured by cfPWV and CAVI method Vascular calcification Inflammation in ESRD patients undergoing chronic HD
ESRD
chronic hemodialysis
arterial stiffness
vascular calcification
sodium thiosulfate
cPWV
CAVI
CT coronary calcium score

ESRD
chronic hemodialysis
arterial stiffness
vascular calcification
sodium thiosulfate
cPWV
CAVI
CT coronary calcium score

Intervention(s)

Active Comparator Drug,No Intervention No treatment

25% Sodium Thiosulfate,Control

25% Sodium thiosulfate 12.5 gram intravenous injection during last hour of hemodialysis 2 times per week, total duration 24 weeks,No intervention is given in this group of subject

Primary Outcome(s)

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

Secondary Outcome(s)

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)

Source(s) of Monetary Support

3

Secondary Sponsor(s)

Ratchadapiseksompotch Fund,The kidney foundation of Thailand

Results

• Date Completed: 31/05/2017