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

NCT ID: NCT00397306

Last Updated: 2009-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Bioimpedance Analysis

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role lead

Principal Investigators

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Eric Seibert, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension

Locations

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

Homburg, Saarland, Germany

Site Status

Countries

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Germany

Other Identifiers

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95/06

Identifier Type: -

Identifier Source: org_study_id

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