End-stage Renal DiseaseNCT02487004
The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients
An observational study of End-stage Renal Disease, run by Su-Hyun Kim at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- hemodialysis
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with end-stage renal disease requiring chronic hemodialysis
Who may be able to join
- 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
Who cannot join
- diagnosed with chronic hepatitis or infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- End-stage Renal Disease
- Being tested
- hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysisDevice
| Study group | Role | What they receive |
|---|---|---|
| chronic hemodialysis patients | Not described Receives: Device: hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
intradialytic sodium gradient
change of serum sodium level between initiation and termination of hemodialysis
Measured: baseline and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Su-Hyun Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Korea, LTD.
- Responsible party
- Sponsor-investigator, Su-Hyun Kim, Chung-Ang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487004
- Sponsor's protocol ID
- CAU-1440
- Status last verified
- Jun 2015
- First submitted
- 25 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02487004
- Acronym / sponsor ID
- CAU-1440
- Conditions
- End-stage Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Su-Hyun KimUniversity, hospital or other
- Collaborators
- Gambro Korea, LTD.
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic hemodialysis patients | – | Device: hemodialysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end-stage renal disease requiring chronic hemodialysis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- diagnosed with chronic hepatitis or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodialysis | Device | chronic hemodialysis patients |
Primary outcome
intradialytic sodium gradient
Time frame: baseline and 4 hours
change of serum sodium level between initiation and termination of hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Su-Hyun Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Hyun Kim, vice professor (1800-1114, sh76so@cau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intradialytic sodium gradient (time frame: baseline and 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.