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OpenTrials
Completed

NCT Number: NCT00397306

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

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Homburg, Saarland, 66421, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioimpedance analysis

Device

Primary outcomes

  1. Bioimpedance Dry weight

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2006
Registry last updated
Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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