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

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ClinicalTrials.gov Identifier: NCT00397306
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
University Hospital, Saarland

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

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Device: Bioimpedance Analysis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Study Start Date : November 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Primary Outcome Measures :
  1. Bioimpedance Dry weight

Secondary Outcome Measures :
  1. Resistance
  2. Resistivity
  3. Blood pressure
  4. LV Diameter
  5. Shortening Fraction
  6. Wall thickness LA, LV
  7. Quality of Life
  8. EPO-Dose


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00397306     History of Changes
Other Study ID Numbers: 95/06
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009

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