Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate

NCT03994133 | Unknown

• 1 other identifier: 2018-A03451-54
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Hemodialysis, Home; Electric Impedance

Keywords

Dialysis; BCM; Daily Home Dialysis; low-flow dialysate; Fluid Overload; kt/V; dialysis dose; Nutritional Status; blood pressure

Outcome Measures

Primary Outcomes (1)

• OH sector measurement by bio-impedancemetry.

  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

  5 minutes

Secondary Outcomes (3)

• Measuring blood pressure

  10 minutes

• EPA scale

  1 minutes

• Mini Nutritional Assessment (MNA) score

  5 minutes

Study Arms (1)

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

Interventions

Measurement of the hydration state by bio-impedance spectroscopy OTHER

* 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

Daily Home Dialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, Normandy, 14000, France

RECRUITING

Related Publications (31)

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  BACKGROUND

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Related Links

• épidémiologie MRC

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

maxence ficheux

CONTACT

+33231063106; ficheux-m@chu-caen.fr

cathy gaillard

CONTACT

+33231065349; gaillard-c@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 21, 2019
• Study Start: June 1, 2019
• Primary Completion: June 10, 2019
• Study Completion: March 1, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-07

Locations

FR (1)