Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate (VOLODIA)
|ClinicalTrials.gov Identifier: NCT03994133|
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : December 17, 2019
The fluid overload measured by the Body Composition Monitor (BCM Fresenius Medical Care) is a new independent risk factor of mortality.
This risk has already been described in intermittent hemodialysis patients and peritoneal dialysis patients but never evaluated in Daily Home Dialysis with low dialysate flow.
The investigator propose a first study measuring the state of hydration by impedancemetry (BCM) in this population.
The aim of this work is to to analyze hydration status in a representative sample of prevalent Daily Home Dialysis with low-flow Dialysate patients.
Secondary objectives are to identify associations between hydration status and patient characteristics and treatment practice in order to find out which conditions should alert the clinician to potential fluid overload, to compare these results with the peritoneal dialysis population and in center hemodialysis population, to evaluate the correlation between impedancemetry and blood pressure in this population, to assess the nutritional status and evaluation of a new method of measurement of kt / V based on impedancemetry, without recourse to a blood test.
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease Requiring Chronic Dialysis Hemodialysis, Home Electric Impedance||Other: Measurement of the hydration state by bio-impedance spectroscopy|
|Study Type :||Observational|
|Estimated Enrollment :||85 participants|
|Official Title:||Contribution of Body Composition Monitor (BCM) Among Patients Using Daily Home Dialysis With Low Dialysate Flow : French Study Cohort|
|Actual Study Start Date :||June 1, 2019|
|Actual Primary Completion Date :||June 10, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Daily Home Dialysis patients
Daily Home Dialysis patients with low-flow dialisate for more than 3 months in France
Other: Measurement of the hydration state by bio-impedance spectroscopy
- OH sector measurement by bio-impedancemetry. [ Time Frame: 5 minutes ]
Two electrodes will be glued to one wrist and two others to the ipsilateral ankle. The measurement is painless.
Distribution of patients in 4 groups:
Normohydrate group: OH between -1.1L and + 1.1L Hypovolemic group: OH <-1.1L Hyperhydrate group: OH between + 1.1L and + 2.5L Heavy hyperhydrate group: OH> + 2.5L
- Measuring blood pressure [ Time Frame: 10 minutes ]After 5 minutes of rest, two consecutive measurements at 5 intervals
- EPA scale [ Time Frame: 1 minutes ]EPA scale is a analogical visual scale of nutrition. Graduated from 0 to 10. 0 = need for nutritional intervention, 10 = good nutritional status
- Mini Nutritional Assessment (MNA) score [ Time Frame: 5 minutes ]30 points, spread over 18 questions from 24 to 30 points: normal nutritional status from 17 to 23.5 points: risk of malnutrition less than 17 points: poor nutritional status
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994133
|Contact: maxence email@example.com|
|Contact: cathy firstname.lastname@example.org|
|CHU de Caen||Recruiting|
|Caen, Normandie, France, 14000|