Status:
COMPLETED
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
Lead Sponsor:
Seca GmbH & Co. Kg.
Conditions:
Kidney Diseases
Eligibility:
All Genders
18-65 years
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01481311
Start Date
January 1 2012
End Date
August 1 2012
Last Update
October 3 2012
Active Locations (1)
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1
Charité University Medicine Berlin
Berlin, State of Berlin, Germany, 10117