NCT01103167

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.

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
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 14, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

April 9, 2010

Last Update Submit

April 13, 2010

Conditions

End Stage Renal Disease

Keywords

body compositionblood pressurehemodialysis

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

    up to 16 weeks

Secondary Outcomes (1)

  • biomarkers

    up to 16 weeks

Interventions

control of ultrafiltrationBEHAVIORAL

During the interventional period, dry weight of patients will be adjusted according to the results of body composition.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sejoong Kim

Incheon, 405-760, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Officials

  • Sejoong Kim, MD, PhD

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sejoong Kim, MD, PhD

CONTACT

82-32-460-8305imsejoong@hanmail.net

Kwon Wook Joo, MD, PhD

CONTACT

82-2-2072-1964junephro@paran.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 14, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

April 14, 2010

Record last verified: 2010-04

Locations

KR(1)