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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00397306
First received: November 7, 2006
Last updated: April 7, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention
Renal Insufficiency, Chronic
 Device: Bioimpedance Analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

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

Enrollment: 16
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397306

Locations
Germany
University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Eric Seibert, M.D. University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00397306     History of Changes
Other Study ID Numbers: 95/06
Study First Received: November 7, 2006
Last Updated: April 7, 2009
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013