NCT00397306

Brief Summary

The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

1.8 years

First QC Date

November 7, 2006

Last Update Submit

April 7, 2009

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

  • Bioimpedance Dry weight

Secondary Outcomes (8)

  • Resistance

  • Resistivity

  • Blood pressure

  • LV Diameter

  • Shortening Fraction

  • +3 more secondary outcomes

Interventions

Bioimpedance AnalysisDEVICE

Eligibility Criteria

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

You may qualify if:

  • clinically stable on dialysis within the last three months
  • signed written informed consent

You may not qualify if:

  • acute myocardial infarction or stroke within the last six months
  • heart failure stage NYHA IV
  • concommitant participation in other interventional trials
  • psychiatric conditions that prevent subject from following the study procedures / protocol
  • pregnancy or lactation
  • limb amputation
  • cardiac pacemaker
  • joint implants
  • implantable pumps and other metallic implants
  • For healthy subjects and CKD patients in stages K/DIGO I-IV the above mentioned criteria other than the first mentioned are applicable respectively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eric Seibert, M.D.

    University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

DE(1)