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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397306
First Posted: November 9, 2006
Last Update Posted: April 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Saarland
November 7, 2006
November 9, 2006
April 8, 2009
November 2006
September 2008   (Final data collection date for primary outcome measure)
Bioimpedance Dry weight
Same as current
Complete list of historical versions of study NCT00397306 on ClinicalTrials.gov Archive Site
  • Resistance
  • Resistivity
  • Blood pressure
  • LV Diameter
  • Shortening Fraction
  • Wall thickness LA, LV
  • Quality of Life
  • EPO-Dose
Same as current
Not Provided
Not Provided
 
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
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
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Renal Insufficiency, Chronic
Device: Bioimpedance Analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2008
September 2008   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00397306
95/06
No
Not Provided
Not Provided
Not Provided
University Hospital, Saarland
Not Provided
Principal Investigator: Eric Seibert, M.D. University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension
University Hospital, Saarland
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP