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Cardiovascular Risk Comparison between Expanded Hemodialysis using Theranova and On-line Hemodiafiltratio

Not Applicable
Completed
Conditions
Diseases of the genitourinary system
Registration Number
KCT0003188
Lead Sponsor
Seoul National University Hospital
Brief Summary

Eighty patients undergoing thrice-weekly hemodialysis were randomly assigned to receive either HDx with a Theranova membrane (n = 43) or online-HDF (n = 37). 65 patients had completed the trial. The changes in baPWV and echocardiographic parameters did not differ between the two groups. The CAC scores remained stable in the online-HDF group, whereas an increasing trend was shown in the HDx group (P = 0.012). Other endpoints, including cardiovascular and all-cause mortalities, were similar between the two groups.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
80
Inclusion Criteria

1. Age = 18 years
2. Hemodialysis due to end-stage renal disease at least for 3 months
3. Informed consent

Exclusion Criteria

1. Perform on-line hemodialysis before enrollment
2. Hemodialysis done not by 3 times per week (e.g. 1 time per week)
3. Peritoneal dialysis together
4. Have a plant to receive kidney transplantation within 1 year
5. Multiple myeloma or monoclonal gammopathy
6. Aggravating cancer status with or without chemotherapy
7. Pregnant, nursing, or plan to be pregnant within 1 year
8. Subjects participating in other clinical trial

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pulse Wave Velocity, PWV
Secondary Outcome Measures
NameTimeMethod
Surrogate marker of cardiovascular disease risk (CT coronary calcium scoring, Transthoracic echocardiography);Blood biomarker of cardiovascular disease risk (BNP & NT-proBNP, High-sensitivity CRP, Troponin I & troponin T, IL-6);Patient-reported outcome
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