Body Composition Monitor in Hemodialysis Patients | NCT01103167

Studies
Body Composition Monitor in Hemodialysis Patients

NCT01103167

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Apr 14, 2010Estimated

Enrollment

160Estimated

Phase

Phase 4

Conditions

End Stage Renal Disease

Interventions

control of ultrafiltration

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Oct 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Apr 9, 2010

First Submission Date that Met QC Criteria

Apr 13, 2010

First Posted Date

Apr 14, 2010Estimated

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

Apr 13, 2010

Last Update Posted Date

Apr 14, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Name	Class
Seoul National University Hospital	OTHER
Seoul National University Bundang Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

Detailed Description

The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.

During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
control of ultrafiltration	Behavioral	During the interventional period, dry weight of patients will be adjusted according to the results of body composition.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood pressure	Systolic blood pressure, number of anti-hypertensive agents hypotensive episode	up to 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
biomarkers	C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF	up to 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6-month or more stable hemodialysis patients
18 years or more
less than 5% of changes of dry weight for last 3 months

Exclusion Criteria:

pregnancy
active malignancy
cardiac pacemaker or defibrillator
history of extremity amputation
active infectious disease within 3 months
admission history for complication related to hemodialysis within 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sejoong Kim, MD, PhD	Contact	82-32-460-8305		imsejoong@hanmail.net
Kwon Wook Joo, MD, PhD	Contact	82-2-2072-1964		junephro@paran.com

Overall Officials

Name	Affiliation	Role
Sejoong Kim, MD, PhD	Gachon University Gil Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sejoong Kim	Recruiting	Incheon		405-760	South Korea

Type	Date	Date Unknown
Release	Oct 1, 2011
Reset	Nov 4, 2011

Submission Tracking

Estimated Results First Submitted Date

Oct 1, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 1, 2011			Nov 4, 2011

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

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Browse Branches

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