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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

BIS-guided Fluid Management in HD Patients

NCT05272800

Kidney Failure Haemodialysis Fluid Adverse Reaction

COMPLETED NA

The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis

NCT03232515

Chronic Renal Failure Dialysis Dry Weight +1 more

COMPLETED NA

Comparison of Body Hydration State in Hemodialysis Patients

NCT01814254

Hemodialysis Chronic Kidney Disease

TERMINATED

Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients

NCT00801112

Fluid Status Peritoneal Dialysis

UNKNOWN

Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension

NCT06279156

Intradialytic Hypotension End Stage Renal Disease on Dialysis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients before dialysis treatment

medical Body Composition Analyzer seca 514/515

Intervention Type DEVICE

Current of 100 µA

Deuterium and Sodium Bromide dilution methods

Intervention Type PROCEDURE

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

Patients after dialysis treatment

medical Body Composition Analyzer seca 514/515

Intervention Type DEVICE

Current of 100 µA

Deuterium and Sodium Bromide dilution methods

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

medical Body Composition Analyzer seca 514/515

Current of 100 µA

Intervention Type DEVICE

Deuterium and Sodium Bromide dilution methods

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No