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Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bioimpedance Analysis
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Bioimpedance Dry weight

Secondary Outcome Measures

Resistance
Resistivity
Blood pressure
LV Diameter
Shortening Fraction
Wall thickness LA, LV
Quality of Life
EPO-Dose

Full Information

First Posted
November 7, 2006
Last Updated
April 7, 2009
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT00397306
Brief Title
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Official Title
Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Bioimpedance Analysis
Primary Outcome Measure Information:
Title
Bioimpedance Dry weight
Secondary Outcome Measure Information:
Title
Resistance
Title
Resistivity
Title
Blood pressure
Title
LV Diameter
Title
Shortening Fraction
Title
Wall thickness LA, LV
Title
Quality of Life
Title
EPO-Dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinically stable on dialysis within the last three months signed written informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Seibert, M.D.
Organizational Affiliation
University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

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