NCT02487004

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

June 25, 2015

Last Update Submit

June 27, 2015

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • intradialytic sodium gradient

    change of serum sodium level between initiation and termination of hemodialysis

    baseline and 4 hours

Study Arms (1)

chronic hemodialysis patients

Device: hemodialysis

Interventions

hemodialysisDEVICE
chronic hemodialysis patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with end-stage renal disease requiring chronic hemodialysis

You may qualify if:

  • 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

You may not qualify if:

  • diagnosed with chronic hepatitis or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Central Study Contacts

Su Hyun Kim, vice professor

CONTACT

1800-1114sh76so@cau.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

KR(1)