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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014