Evaluation of a Bioimpedance Method for Determination of... | NCT00397306

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

NCT00397306

Sponsor

University Hospital, Saarland

Status

Completed

Last Update Posted

Apr 8, 2009Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Renal Insufficiency, Chronic

Interventions

Bioimpedance Analysis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Nov 7, 2006

First Submission Date that Met QC Criteria

Nov 7, 2006

First Posted Date

Nov 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2009

Last Update Posted Date

Apr 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Name	Type	Description	Arm Group Labels	Other Names
Bioimpedance Analysis	Device

Measure	Description	Time Frame
Bioimpedance Dry weight

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Seibert, M.D.	University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension		Homburg	Saarland	66421	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Resistance
Resistivity
Blood pressure