NCT01481311

Brief Summary

The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. Abnormal high water distribution is defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

November 10, 2011

Last Update Submit

October 2, 2012

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side

    The measurements are utilized as input for prediction equations to calculate TBW and ECW.

    about 2 minutes

Secondary Outcomes (3)

  • Bioelectrical impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz

    about 2 minutes

  • TBW

    within 4 hours

  • ECW

    within 4 hours

Study Arms (2)

Patients before dialysis treatment

Device: medical Body Composition Analyzer seca 514/515Procedure: Deuterium and Sodium Bromide dilution methods

Patients after dialysis treatment

Device: medical Body Composition Analyzer seca 514/515Procedure: Deuterium and Sodium Bromide dilution methods

Interventions

medical Body Composition Analyzer seca 514/515DEVICE

Current of 100 µA

Patients after dialysis treatmentPatients before dialysis treatment
Deuterium and Sodium Bromide dilution methodsPROCEDURE

Orally administered to the subject in a solution with 100 ml tap water.

Patients after dialysis treatmentPatients before dialysis treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Data of 50 patients suffering from kidney disease are planned to be collected.

You may qualify if:

  • The study will cover 50 adults. Men and women in an age range of 18 to 65 years and a Body Mass Index (BMI) range of 18.5 to 35 kg/m2 should be equally distributed. Subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. Patients that are taken before dialysis treatment should have been dialysed two and not three days before.

You may not qualify if:

  • amputation of limbs
  • gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis
  • bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia
  • electrical implant as cardiac pacemaker
  • insulin pumps
  • pregnancy or breastfeeding period
  • subjects who cannot provide an Informed Consent Form (ICF) by themselves
  • subjects who might be dependent from the sponsor or the investigation site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Deuterium

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HydrogenElementsInorganic ChemicalsGasesIsotopes

Study Officials

  • Torsten Slowinski, Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 29, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

DE(1)