Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate
Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate
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.
Study objectives

 This study is a cross sectional, observational trial in 11 centers in France. The primary
 objective is 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.

 Centers

 Participants in this study are: CHU de Caen, Tenon Hospital, CHG Saint-Lô, CHG Alençon, CHG
 Flers, CHG Lisieux, CHG Evreux, ANIDER Rouen, CHG Le Havre, A.U.B Rennes, A.D.P.C Marseille.

 Patients

 In each center, all prevalent patients, for more than 3 months, on Daily Home Dialysis with
 Low-flow Dialysate are assessed for eligibility for inclusion if they are older than 18 years
 of age and want to sign informed consent. Patients are excluded if they have a cardiac
 pacemaker or metallic implants, are amputees or are pregnant. Patients are evaluated during a
 routine clinical visit. All patients will signed informed consent, and ethical advice is
 obtained.

 Measurements of hydration and body composition

 BCM measurements will be performed in each center by one reference physician or nurse, using
 a portable whole body bioimpedance spectroscopy device, the BCM (Fresenius Medical Care). The
 BCM measures the impedance spectroscopy at 50 different frequencies between 5 kHz and 1 MHz.
 The BCM was validated intensively against all available gold-standard methods.

 The measurement will be performed in pre-dialysis, electrodes will be attached to one hand
 and one foot at the ipsilateral side, after the patient will be in recumbent position for at
 least 5 minutes. Reproducibility of BCM derived parameters is high, with a coefficient of
 variation for the interobserver variability ECW and TBW around 1.2%. Therefore, only one BCM
 measurement is performed in each individual patient.

 Extracellular water (ECW), intracellular water (ICW) and total body water (TBW) are
 determined from the measured impedance data following the model of Moissl et al en 2006.

 Fluid overload is expressed by a compartment called OH (overhydration). OH represents the
 difference between the amount of ECW in the tissue as actually detected by the BCM and the
 amount of water present in tissue, as predicted by physiological models under normal
 physiological (normohydrated) conditions. Of note, OH has no direct relation to circulating
 volume.

 Four hydrations groups are defined, based on studies by Wieskotten et al. on healthy
 population and Wabel et al. on a dialysis population: Normohydrate group: OH between -1.1L
 and + 1.1L (corresponding to the 10th and 90th percentiles of a population of the same gender
 distribution and with a comparable age band out of a healthy reference cohort, where
 hydration status was measured with the identical technology); Hypovolemic group: OH <-1.1L;
 Fluid overload group: OH between + 1.1L and + 2.5L; Severe fluid overload group: OH> + 2.5L.

 The post-dialysis OH status will be obtained by the difference between pre-dialysis OH
 obtained by impedancemetry and the UF performed.

 Blood pressure will be performed in pre-dialytic and post-dialytic and is recorded as the
 mean of two consecutive measurements with 5 minutes interval, using one single calibrated
 device in each center. The investigator defined 3 groups according to pre-dialysis systolic
 blood pressure (SBP): Hypertensive: SBP > 140 mmHg; Normotendu: SBP [100-140 mmHg];
 Hypotensive: SBP < 100 mmHg.

 Height and weight will be measured using one single calibrated device in each center.

 Clinically relevant parameters will be registered in the case report form (CRF).

 Nutritional assessment

 Nutritional status is evaluated using three methods:

 The first one is The Mini Nutritional Assessment (MNA), on 30 points, is a questionnaire of
 18 questions to define three groups: 24-30 points: normal nutritional status; 17-23.5 points:
 risk of malnutrition and < 17 points: poor nutritional status.

 The second one is the Scale of Assessment of the food intake (EPA) is a rapid tool based on
 self-assessment by analog scale from 0 to 10. An EPA> 7 should result in nutritional
 management.

 The third is according to the impedancemetry. The BCM (Fresenius Medical Care), provides,
 according to Chamney et al. Model, two parameters: "LTM" and "FTM" for "lean tissue mass" and
 "fat tissue mass". The values obtained will be normalized to the body surface, to allow a
 comparison between patients of different size, thus giving the lean tissue index (LTI = LTM /
 height2) and the fat tissue index (FTI = FTM / height2). The values for LTI and FTI will be
 compared to a healthy reference population matched by age and sex. Values below the 10th
 percentile of the reference population will be considered clinically significant.

 Résults were registered in the case report form (CRF).

 Patient characteristics

 All this information will be collected using two questionnaires given to one reference
 physician or nurse and the patient respectively.

 The investigator identified diabetes (assumed to be present in patients using glucose
 lowering drugs or insulin), nephropathy, residual diuresis, comorbidities allowing the
 calculation of the Charlson score, numbers of antihypertensive drugs, hospitalization less
 than three months old, history of peritoneal dialysis and / or transplantation.

 Concerning the daily practice of home dialysis the investigator identified ultrafiltration,
 blood flow, length of sessions, type of vascular access and creation date, the usual time of
 the session, the person performing the fistula puncture at home, needle type, frequent
 problem with connection, observance of dialysis sessions, date of installation at home The
 following biochemical parameters will be determined in the local laboratories from blood
 collected during the routine visit. Predialytic dosage: hemoglobin, hematocrit, platelets,
 leukocytes, urea, creatinine, serum iron, CST, ferritin, sodium, chlorine, potassium,
 magnesium, alkaline reserve, protidemia, albumin, prealbumin, CRP, PTH, calcium, phosphorus,
 BNP, B2-microglobulin. Postdialytic dosage: sodium, chlorine, potassium, alkaline reserve,
 urea, protidemia, B2-microglobulin.

 New Kt/V measurement method

 Conventionally in dialysis patients, the dialysis dose is represented by the formula kt / V,
 with: k= plasma clearance of urea; t= unit of time; V= volume of distribution of urea in
 dialysis patient.

 The current assessment is Daugirdas2: Kt / V = -ln (R- (0.008 * t) + ((4 (3.5 * R)) * UF%),
 with: R= Urea after / Urea before; t= time of the session (hour); UF%= 100*/post-dialysis
 weight, Our current method therefore requires a plasma dosage of urea at the beginning and
 end of the session.

 The investigator propose a new measurement method where the V will be obtained by
 impedancemetry and the t corresponds to the duration of the session. For k, the investigator
 rely on the fact that in vitro (27), at low dialysate flow rate, the saturation of the
 dialysate in urea is constant, and therefore that the k can be represented by the formula: k
 = ax Qd (with a: saturation constant and Qd: dialysate flow) Therefore, the investigator
 propose the following formula: Dialysis dose = a x Qd x t / V This is a new measurement
 method with important clinical relevance since it avoids two blood tests and two biological
 tests.

 The investigator would therefore like to assume that the measure of kt / V would be
 equivalent between the formula the investigator would like to test and the conventional
 formula, either: a x Qd x t / V ≡ kt / V Daugirdas2
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.