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Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate (VOLODIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994133
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
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
  • The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).
  • The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes.
  • The measurement will be done in pre-dialytic




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Measuring blood pressure [ Time Frame: 10 minutes ]
    After 5 minutes of rest, two consecutive measurements at 5 intervals

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic end-stage renal disease in home daily hemodialysis with dialysate low for more than three months in France
Criteria

Inclusion Criteria:

  • Patient with chronic end stage renal failure
  • Patient prevalent in home daily hemodialysis with low dialysate rate for more than 3 months.
  • Patient followed at the University Hospital of Caen, Tenon Hospital (Paris), CHG Saint-Lô, CHG Alençon, CHG Flers, CHG Lisieux, CHG Evreux, ANIDER Rouen, CH Le Havre, A.U.B Rennes, A.D.P.C. Marseille

Exclusion Criteria:

  • Reversindication to impedancemetry: patient with a pacemaker or an implantable defibrillator,
  • Population not validated for impedancemetry: pregnant or lactating woman, major amputation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994133


Contacts
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Contact: maxence ficheux +33231063106 ficheux-m@chu-caen.fr
Contact: cathy gaillard +33231065349 gaillard-c@chu-caen.fr

Locations
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France
CHU de Caen Recruiting
Caen, Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Additional Information:
Publications:
Wabel P, Chamney P, Moissl U (2007) Reproducibility of bioimpedance spectroscopy for the assessment of body composition and dry weight. J Am Soc Nephrol 18: A255
Cole, K. S., & Cole, R. H. (1941). Dispersion and absorption in dielectrics I. Alternating current characteristics. The Journal of chemical physics, 9(4), 341-351.

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03994133    
Other Study ID Numbers: 2018-A03451-54
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Dialysis
BCM
Daily Home Dialysis
low-flow dialysate
Fluid Overload
kt/V
dialysis dose
Nutritional Status
blood pressure
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency