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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397306
• Other study ID #: 95/06
• Status: Completed
• Phase: N/A
• First received: November 7, 2006
• Last updated: April 7, 2009
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2009
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Bioimpedance Analysis

Locations

Country	Name	City	State
Germany	University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioimpedance Dry weight
Secondary	Resistance
Secondary	Resistivity
Secondary	Blood pressure
Secondary	LV Diameter
Secondary	Shortening Fraction
Secondary	Wall thickness LA, LV
Secondary	Quality of Life
Secondary	EPO-Dose