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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02487004
Other study ID # CAU-1440
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 25, 2015
Last updated June 27, 2015
Start date July 2015
Est. completion date December 2016

Study information

Verified date June 2015
Source Chung-Ang University
Contact Su Hyun Kim, vice professor
Phone 1800-1114
Email sh76so@cau.ac.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether the change of serum and dialysate sodium level during hemodialysis can influence on blood pressure and intradialytic weight gain in chronic hemodialysis patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- age 20 years or more

- hemodialysis vintage over 3 months

- dialyzed for 4 hours three times per week

- hemodialysis adequacy (Kt/V) over 1.2

Exclusion Criteria:

- diagnosed with chronic hepatitis or infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
hemodialysis


Locations

Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Su-Hyun Kim Gambro Korea, LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary intradialytic sodium gradient change of serum sodium level between initiation and termination of hemodialysis baseline and 4 hours No
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