The Study of Association Between Intradialysis Sodium Bal... | NCT02487004

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

NCT02487004

Sponsor

Su-Hyun Kim

Status

Unknown status

Last Update Posted

Jul 1, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

End-stage Renal Disease

Interventions

hemodialysis

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jun 25, 2015

First Submission Date that Met QC Criteria

Jun 27, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2015

Last Update Posted Date

Jul 1, 2015Estimated

Name	Class
Gambro Korea, LTD.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
chronic hemodialysis patients			Device: hemodialysis

Name	Type	Description	Arm Group Labels	Other Names
hemodialysis	Device		chronic hemodialysis patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with end-stage renal disease requiring chronic hemodialysis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Su Hyun Kim, vice professor	Contact	1800-1114		sh76so@cau.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-Ang University Hospital		Seoul		156-755	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006435	Renal Dialysis

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification

Browse Leaves

Not provided

Browse Branches

Not provided