Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)

Seca

Status: Completed

Conditions: Kidney Diseases

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01481311

BCA-05

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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

Trial design

62 participants in 2 patient groups

Patients before dialysis treatment

Treatment:

Device: medical Body Composition Analyzer seca 514/515

Procedure: Deuterium and Sodium Bromide dilution methods

Patients after dialysis treatment

Treatment:

Device: medical Body Composition Analyzer seca 514/515

Procedure: Deuterium and Sodium Bromide dilution methods