The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients

June 27, 2015 updated by: Su-Hyun Kim
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with end-stage renal disease requiring chronic hemodialysis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic hemodialysis patients
Device: hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intradialytic sodium gradient
Time Frame: baseline and 4 hours
change of serum sodium level between initiation and termination of hemodialysis
baseline and 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Su-Hyun Kim

Collaborators

Gambro Korea, LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 27, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 27, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAU-1440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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