<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03232515</url>
  </required_header>
  <id_info>
    <org_study_id>DMCS/CBIDMCS/D-87bis</org_study_id>
    <nct_id>NCT03232515</nct_id>
  </id_info>
  <brief_title>The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis</brief_title>
  <official_title>The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Sonora</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Sonora</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in&#xD;
      clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the&#xD;
      patient will not develop symptoms of hypotension and edema, in addition to not using&#xD;
      antihypertensives. Achieving a fluid balance benefits the control of blood pressure and&#xD;
      reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective&#xD;
      method dependent on the signs and symptoms that the patient presents. Recently, several&#xD;
      approaches have been studied to develop a standardized DW evaluation technique. Among these,&#xD;
      the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and&#xD;
      promising method with high reproducibility.&#xD;
&#xD;
      OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal&#xD;
      failure undergoing hemodialysis.&#xD;
&#xD;
      Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of&#xD;
      patients comes from the hemodialysis unit of the General State Hospital of Sonora.&#xD;
&#xD;
      Patients who have limb amputations, pacemakers, metal implants, who are under renal&#xD;
      transplant protocol or who have a renal transplant, and presence of infectious foci will be&#xD;
      restricted from participating.&#xD;
&#xD;
      The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid&#xD;
      status will be evaluated using BIVA. Measurements will be made before and after HD in three&#xD;
      consecutive weekly periods and one one final assessment at three months.&#xD;
&#xD;
      At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin,&#xD;
      pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition&#xD;
      Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body&#xD;
      composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm&#xD;
      circumference and dynamometry. The dialysis dose received will be modified according to BIVA.&#xD;
&#xD;
      The main variables to be considered will be DW, extracellular water and blood pressure.&#xD;
&#xD;
      The duration of the study will be approximately 6 months. In addition, at the end of each&#xD;
      measurement, each participant will be given a nutritional recommendation (feeding guide)&#xD;
      specific to their energy requirements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Place of study: General Hospital of the State of Sonora &quot;Dr. Ernesto Ramos Bours&quot; in the&#xD;
           city of Hermosillo, Sonora.&#xD;
&#xD;
        -  Sociodemographic and symptomatological information questionnaire: Questionnaires will be&#xD;
           applied to each participant, which will allow to obtain information of their occupation,&#xD;
           residence, date of birth, their own medical and family history, as well as typical&#xD;
           symptoms of the diseases.&#xD;
&#xD;
        -  Weight: The weight will be measured with a SECA Model 813 Portable Floor Scale. The&#xD;
           person should wear light clothing, empty pockets, without shoes, accessories (belts,&#xD;
           necklaces, watches, etc.); In a firm position, facing forward, without movement at the&#xD;
           time of taking the measurement. Weight measurement should be the simplest and most&#xD;
           accurate of anthropometric measurements, the balance should be calibrated periodically.&#xD;
&#xD;
        -  Height: The height will be measured with a portable stadiometer Model 217 SECA. The&#xD;
           participant is presented for the measurement of the height dressed with the minimum of&#xD;
           clothes, at least, without shoes and socks. The participant is instructed to stand on&#xD;
           the stadiometer so that his heels, gluteus, and shoulder blades are in contact with the&#xD;
           back plate, and the heels together. The head should be placed on the &quot;Frankfurt Plane&quot;,&#xD;
           the head of the instrument will move down to make contact with the apex of the skull.&#xD;
           With the subject in the correct position, he is instructed: &quot;take a deep breath and&#xD;
           stand tall&quot;. The height is measured at the point of inspiration without pressure being&#xD;
           applied.&#xD;
&#xD;
        -  Single-frequency bioimpedance (BIA): The BIA measurement will be performed according to&#xD;
           the established criteria by the National Institute of Health Technology Assessment&#xD;
           Conference Statement. The subject will be placed supine, with arms and legs separated&#xD;
           from the body and palms down. The electrodes will be located in the right extremities,&#xD;
           located on the back of the hand and foot near the phalangeal-metacarpal and&#xD;
           phalangeal-metatarsal joints and in the styloid process of the wrist and between the&#xD;
           medial and lateral malleolus of the ankle, through which an imperceptible electric&#xD;
           current will be introduced.&#xD;
&#xD;
      The subjects should be under the following conditions so that the study can be carried out:&#xD;
&#xD;
        -  Fast four hours before the measurement.&#xD;
&#xD;
        -  Not having consumed alcoholic beverages during the 48 hours prior to the test.&#xD;
&#xD;
        -  No strenuous exercise 24 hours prior to measurement.&#xD;
&#xD;
        -  In the case of women, do not menstruate.&#xD;
&#xD;
        -  Do not have any metal objects on the body.&#xD;
&#xD;
        -  The approximate measurement time is five minutes.&#xD;
&#xD;
             -  Vector analysis of electric bioimpedance (BIVA): The variables of resistance (R),&#xD;
                Reactance (Xc) and size of each of the individuals measured to be plotted in the&#xD;
                reference ellipses of the Mexican population by sex will be used. The R and Xc&#xD;
                standardized by size (R / size and Xc / size) will be used to plot the vector of&#xD;
                individuals within the percentiles 50, 75 and 95% of tolerance ellipses,&#xD;
                differentiated by sex, using the BIVA program Software 2002.&#xD;
&#xD;
             -  Clinical assessment of dry weight and hemodialysis (HD) process: Based on the&#xD;
                traditional practices of the Hospital dialysis unit, the physician / nurse will&#xD;
                perform physical examination and interpret the signs and symptoms associated with&#xD;
                the renal disease, these are blood pressure , heart rate, respiratory rate,&#xD;
                temperature, presence of infection and edema. This will include present and past&#xD;
                health-disease aspects, medications, as well as information on the patient's daily&#xD;
                life. Upon arrival, the patient will be weighed according to the methodology&#xD;
                described above. According to the traditional practice of the Hospital Dialysis&#xD;
                Unit, the patient's target weight will be based on the difference between the&#xD;
                post-dialysis weight of the last session and the current weight, in addition to&#xD;
                taking into account the signs and symptoms Mentioned above, In order to determine&#xD;
                the excess water of the patient.&#xD;
&#xD;
      The amount of fluid to be withdrawn to the patient, the ultrafiltration rate and the duration&#xD;
      time are determined by the nephrologist physician in consultation prior to the HD session.&#xD;
      Such information may be modified in the HD session depending on the clinical evaluation of&#xD;
      the patient on the day of treatment.&#xD;
&#xD;
      Before starting HD, the patient's vascular access is prepared with three alcohol times and&#xD;
      three times of 10% EXSEPT, and the clot is removed from the access.&#xD;
&#xD;
      The time, ultrafiltration rate and the amount of liquid to be filtered on the HD machine&#xD;
      (Fresenius Medical Care 4008 S - OCM Kt / V) are then programmed. Once programmed, it&#xD;
      connects To the patient and heparin is administered at an initial bolus and at each hour of&#xD;
      treatment. A total of 100 units per kg of body weight is given and the total is divided&#xD;
      between the initial bolus and each hour of treatment. The mechanism by which the HD machine&#xD;
      works is as follows: A pump directs the patient's blood to a filter of Polysulfone fibers,&#xD;
      blood runs up-down, while a dialysing solution (its content is similar to normal blood&#xD;
      plasma) flows in the opposite direction. By means of osmosis and the pressure exerted by the&#xD;
      filter, excess substances are removed from the patient's blood and, if any of the plasma&#xD;
      components are deficient, is absorbed from the dialysing solution. The blood is returned to&#xD;
      the patient and heparin is supplied at both catheter outlets to avoid coagulation. The&#xD;
      catheter is then sealed with a stopper and a patch is placed to prevent contact with the&#xD;
      outside medium. Finally, the vital signs are reviewed again and the appointment is scheduled&#xD;
      for the next treatment. In case the vital signs are altered, the patient is immediately&#xD;
      referred to the emergency department.&#xD;
&#xD;
        -  Laboratory parameters: Pre and post-dialysis patient blood samples will be taken to&#xD;
           analyze the following parameters: serum electrolytes, blood biometrics, blood chemistry&#xD;
           and Hepatic function. If feasible, the PCR will be analyzed.&#xD;
&#xD;
        -  Blood pressure: Blood pressure will be measured with an automatic monitor included in&#xD;
           the hemodialysis equipment (Fresenius Medical Care 4008 S - OCM Kt / V). To perform the&#xD;
           measurement, the patient has to be relaxed and seated comfortably, at a comfortable&#xD;
           ambient temperature. Do not bathe, drink alcohol or caffeine, smoke, exercise or eat 30&#xD;
           minutes before taking the measurement. The participants should sit in a chair with their&#xD;
           feet flat on the floor, the back straight and the arm band should be at the same level&#xD;
           as their heart with the palm up and relaxed. The nurse will start by palpating the arm&#xD;
           for the pulse of the brachial artery, where the diaphragm of the stethoscope will be&#xD;
           placed. This artery is located between the brachial and brachial biceps muscles; In its&#xD;
           lower-lateral path accompanies the median nerve. The bracelet should be placed to take&#xD;
           the measurement.Special considerations: - In patients with peripheral insertion of&#xD;
           central catheters, the upper arm should be avoided in which there is a central&#xD;
           peripheral insertion catheter. - In patients with a bypass Dialysis, or fistula, blood&#xD;
           pressure should be taken in the opposite arm if the patient has an arteriovenous&#xD;
           insertion or fistula necessary for dialysis, this is to avoid possible trauma or clot&#xD;
           formation.&#xD;
&#xD;
        -  Nutritional intervention: Patients will be made aware of the importance of adherence to&#xD;
           nutritional treatment through individualized sessions, addressing the following topics:&#xD;
           a) how to ensure adequate energy and protein intake, b) how to control fluid, sodium and&#xD;
           potassium intake, identifying foods rich in them, c) Incorrect feeding, d) food&#xD;
           preparation techniques, among others. Also, in each session, depending on the patient's&#xD;
           nutritional status, laboratory values and comorbidities, a personalized feeding guide&#xD;
           will be provided, which will include the foods to be consumed and in what quantities,&#xD;
           using the Mexican equivalents system for renal patients and the current Kidney Disease&#xD;
           Improving Global Outcomes (KDIGO) practice guidelines.&#xD;
&#xD;
        -  Malnutrition Inflammation Score (MIS), Bilbrey Index and subjective global assessment:&#xD;
           These are instruments that will be used to establish a Nutritional diagnosis of each&#xD;
           patient. Clinical, biochemical and anthropometric parameters are evaluated. Each of the&#xD;
           measurements will be made according to the current standardized methodology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">August 7, 2018</completion_date>
  <primary_completion_date type="Actual">February 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Non-randomized pre-test / post-test clinical trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Systolic Blood Pressure at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>(mm Hg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Dry weight at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>(Kg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>6 months</time_frame>
    <description>Meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Tricep skinfold at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elbow width</measure>
    <time_frame>6 months</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Arm circumference at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Dynamometry at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Seric glucose at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Seric cholesterol at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Seric creatinine at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Total proteins at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Albumin at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Pre-albumin at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Blood urea nitrogen at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Reactive C protein at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Chloride at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>meq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>6 months</time_frame>
    <description>meq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Potassium at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>meq/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Calcium at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Magnesium at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Phosphorus at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Transferrin at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Lymphocytes at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Leukocytes at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>(10^3)/uL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Single frequency bioimpedance at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Resistance and Reactance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Nutritional Status at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Bilbrey Index (BI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Extracellular water at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>(Liters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Nutritional Status at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Subjective Global Assessment (SGA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Nutritional Status at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Malnutrition-Inflammation Score (MIS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Chronic Renal Failure</condition>
  <condition>Dialysis</condition>
  <condition>Dry Weight</condition>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation,estimation and modification of the dry weight by BIVA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA</intervention_name>
    <description>Using the BIVA method, excess fluid will be estimated in patients with chronic renal failure undergoing hemodialysis in order to obtain a better estimate of dry weight and thus improve the quality of life of patients.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be patient of the Hospital&#xD;
&#xD;
          -  Diagnosed with chronic renal failure (KDOQI stage 5)&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  Undergoing Hemodialysis treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Amputations&#xD;
&#xD;
          -  Have metalic implants&#xD;
&#xD;
          -  Have pacemaker&#xD;
&#xD;
          -  Renal transplant (or in protocol to receive it)&#xD;
&#xD;
          -  Infectious processes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Eduardo Valencia Juillerat, P.H.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Sonora</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General del Estado de Sonora &quot;Dr. Ernesto Ramos Bours&quot;</name>
      <address>
        <city>Hermosillo</city>
        <state>Sonora</state>
        <zip>83000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>https://www.kidney.org/professionals/guidelines</url>
    <description>The National Kidney Foundation produces clinical practice guidelines through the NKF Kidney Disease Outcomes Quality Initiative (NKF KDOQI)™. This program has provided evidence-based guidelines for all stages of chronic kidney disease (CKD)</description>
  </link>
  <reference>
    <citation>Lavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011.</citation>
  </reference>
  <reference>
    <citation>Bekheirnia MR, Schrier RW. Pathophysiology of water and sodium retention: edematous states with normal kidney function. Curr Opin Pharmacol. 2006 Apr;6(2):202-7. doi: 10.1016/j.coph.2005.09.008. Epub 2006 Feb 17.</citation>
    <PMID>16483846</PMID>
  </reference>
  <reference>
    <citation>Chaney E, Shaw A. Pathophysiology of fluid retention in heart failure. Contrib Nephrol. 2010;164:46-53. doi: 10.1159/000313720. Epub 2010 Apr 20.</citation>
    <PMID>20427993</PMID>
  </reference>
  <reference>
    <citation>Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063.</citation>
    <PMID>12953039</PMID>
  </reference>
  <reference>
    <citation>Muldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6.</citation>
  </reference>
  <reference>
    <citation>Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. Am Fam Physician. 2013 Jul 15;88(2):102-10.</citation>
    <PMID>23939641</PMID>
  </reference>
  <reference>
    <citation>Casey G. Oedema: causes, physiology and nursing management. Nurs Stand. 2004 Sep 1-7;18(51):45-51; quiz 52. doi: 10.7748/ns.18.51.45.s54.</citation>
    <PMID>15487497</PMID>
  </reference>
  <reference>
    <citation>Cameron N. Essential anthropometry: Baseline anthropometric methods for human biologists in laboratory and field situations. Am J Hum Biol. 2013 May-Jun;25(3):291-9. doi: 10.1002/ajhb.22388. No abstract available.</citation>
    <PMID>23606226</PMID>
  </reference>
  <reference>
    <citation>National Institute for Health and Care Excellence (NICE). The BCM - Body Composition Monitor for managing fluid in people having dialysis. Medtech innovation briefing. Published: 13 October 2015</citation>
  </reference>
  <reference>
    <citation>Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for physical therapists. Cardiopulm Phys Ther J. 2011 Jun;22(2):5-12.</citation>
    <PMID>21637392</PMID>
  </reference>
  <reference>
    <citation>Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009</citation>
  </reference>
  <reference>
    <citation>Piccoli A, Nescolarde LD, Rosell J. [Conventional and vectorial analysis of bioimpedance in clinical practice]. Nefrologia. 2002;22(3):228-38. No abstract available. Spanish.</citation>
    <PMID>12123122</PMID>
  </reference>
  <reference>
    <citation>NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994. Nutrition. 1996 Nov-Dec;12(11-12):749-62.</citation>
    <PMID>8974099</PMID>
  </reference>
  <results_reference>
    <citation>Jian Y, Li X, Cheng X, Chen Y, Liu L, Tao Z, Zuo L. Comparison of bioimpedance and clinical methods for dry weight prediction in maintenance hemodialysis patients. Blood Purif. 2014;37(3):214-20. doi: 10.1159/000362109. Epub 2014 Jun 5.</citation>
    <PMID>24902760</PMID>
  </results_reference>
  <results_reference>
    <citation>Hyun SH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Assessment of fluid and nutritional status using multifrequency bioelectrical impedance analysis in peritoneal dialysis patients. Blood Purif. 2014;37(2):152-62. doi: 10.1159/000360272. Epub 2014 Apr 26.</citation>
    <PMID>24777057</PMID>
  </results_reference>
  <results_reference>
    <citation>Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.</citation>
    <PMID>23732715</PMID>
  </results_reference>
  <results_reference>
    <citation>Atilano-Carsi X, Miguel JL, Martinez Ara J, Sanchez Villanueva R, Gonzalez Garcia E, Selgas Gutierrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1;31(5):2220-9. doi: 10.3305/nh.2015.31.5.8649. Spanish.</citation>
    <PMID>25929397</PMID>
  </results_reference>
  <results_reference>
    <citation>Espinosa-Cuevas Mde L, Rivas-Rodriguez L, Gonzalez-Medina EC, Atilano-Carsi X, Miranda-Alatriste P, Correa-Rotter R. [Bioimpedance vector analysis for body composition in Mexican population]. Rev Invest Clin. 2007 Jan-Feb;59(1):15-24. Spanish.</citation>
    <PMID>17569296</PMID>
  </results_reference>
  <results_reference>
    <citation>Espinosa Cuevas MA, Navarrete Rodriguez G, Villeda Martinez ME, Atilano Carsi X, Miranda Alatriste P, Tostado Gutierrez T, Correa-Rotter R. Body fluid volume and nutritional status in hemodialysis: vector bioelectric impedance analysis. Clin Nephrol. 2010 Apr;73(4):300-8.</citation>
    <PMID>20353738</PMID>
  </results_reference>
  <results_reference>
    <citation>Gonzalez-Ortiz AJ, Arce-Santander CV, Vega-Vega O, Correa-Rotter R, Espinosa-Cuevas Mde L. Assessment of the reliability and consistency of the &quot;malnutrition inflammation score&quot; (MIS) in Mexican adults with chronic kidney disease for diagnosis of protein-energy wasting syndrome (PEW). Nutr Hosp. 2014 Oct 4;31(3):1352-8. doi: 10.3305/nh.2015.31.3.8173.</citation>
    <PMID>25726233</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Sonora</investigator_affiliation>
    <investigator_full_name>Mauro Eduardo Valencia Juillerat</investigator_full_name>
    <investigator_title>P.H.D. Principal researcher</investigator_title>
  </responsible_party>
  <keyword>Bioimpedance Vector Analysis (BIVA)</keyword>
  <keyword>Chronic Renal Failure</keyword>
  <keyword>Dialysis</keyword>
  <keyword>Dry weight</keyword>
  <keyword>Blood Pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232515
org study id: DMCS/CBIDMCS/D-87bis
nct id: NCT03232515
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in
      clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the
      patient will not develop symptoms of hypotension and edema, in addition to not using
      antihypertensives. Achieving a fluid balance benefits the control of blood pressure and
      reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective
      method dependent on the signs and symptoms that the patient presents. Recently, several
      approaches have been studied to develop a standardized DW evaluation technique. Among these,
      the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and
      promising method with high reproducibility.

      OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal
      failure undergoing hemodialysis.

      Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of
      patients comes from the hemodialysis unit of the General State Hospital of Sonora.

      Patients who have limb amputations, pacemakers, metal implants, who are under renal
      transplant protocol or who have a renal transplant, and presence of infectious foci will be
      restricted from participating.

      The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid
      status will be evaluated using BIVA. Measurements will be made before and after HD in three
      consecutive weekly periods and one one final assessment at three months.

      At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin,
      pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition
      Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body
      composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm
      circumference and dynamometry. The dialysis dose received will be modified according to BIVA.

      The main variables to be considered will be DW, extracellular water and blood pressure.

      The duration of the study will be approximately 6 months. In addition, at the end of each
      measurement, each participant will be given a nutritional recommendation (feeding guide)
      specific to their energy requirements.
-  Place of study: General Hospital of the State of Sonora "Dr. Ernesto Ramos Bours" in the
           city of Hermosillo, Sonora.

        -  Sociodemographic and symptomatological information questionnaire: Questionnaires will be
           applied to each participant, which will allow to obtain information of their occupation,
           residence, date of birth, their own medical and family history, as well as typical
           symptoms of the diseases.

        -  Weight: The weight will be measured with a SECA Model 813 Portable Floor Scale. The
           person should wear light clothing, empty pockets, without shoes, accessories (belts,
           necklaces, watches, etc.); In a firm position, facing forward, without movement at the
           time of taking the measurement. Weight measurement should be the simplest and most
           accurate of anthropometric measurements, the balance should be calibrated periodically.

        -  Height: The height will be measured with a portable stadiometer Model 217 SECA. The
           participant is presented for the measurement of the height dressed with the minimum of
           clothes, at least, without shoes and socks. The participant is instructed to stand on
           the stadiometer so that his heels, gluteus, and shoulder blades are in contact with the
           back plate, and the heels together. The head should be placed on the "Frankfurt Plane",
           the head of the instrument will move down to make contact with the apex of the skull.
           With the subject in the correct position, he is instructed: "take a deep breath and
           stand tall". The height is measured at the point of inspiration without pressure being
           applied.

        -  Single-frequency bioimpedance (BIA): The BIA measurement will be performed according to
           the established criteria by the National Institute of Health Technology Assessment
           Conference Statement. The subject will be placed supine, with arms and legs separated
           from the body and palms down. The electrodes will be located in the right extremities,
           located on the back of the hand and foot near the phalangeal-metacarpal and
           phalangeal-metatarsal joints and in the styloid process of the wrist and between the
           medial and lateral malleolus of the ankle, through which an imperceptible electric
           current will be introduced.

      The subjects should be under the following conditions so that the study can be carried out:

        -  Fast four hours before the measurement.

        -  Not having consumed alcoholic beverages during the 48 hours prior to the test.

        -  No strenuous exercise 24 hours prior to measurement.

        -  In the case of women, do not menstruate.

        -  Do not have any metal objects on the body.

        -  The approximate measurement time is five minutes.

             -  Vector analysis of electric bioimpedance (BIVA): The variables of resistance (R),
                Reactance (Xc) and size of each of the individuals measured to be plotted in the
                reference ellipses of the Mexican population by sex will be used. The R and Xc
                standardized by size (R / size and Xc / size) will be used to plot the vector of
                individuals within the percentiles 50, 75 and 95% of tolerance ellipses,
                differentiated by sex, using the BIVA program Software 2002.

             -  Clinical assessment of dry weight and hemodialysis (HD) process: Based on the
                traditional practices of the Hospital dialysis unit, the physician / nurse will
                perform physical examination and interpret the signs and symptoms associated with
                the renal disease, these are blood pressure , heart rate, respiratory rate,
                temperature, presence of infection and edema. This will include present and past
                health-disease aspects, medications, as well as information on the patient's daily
                life. Upon arrival, the patient will be weighed according to the methodology
                described above. According to the traditional practice of the Hospital Dialysis
                Unit, the patient's target weight will be based on the difference between the
                post-dialysis weight of the last session and the current weight, in addition to
                taking into account the signs and symptoms Mentioned above, In order to determine
                the excess water of the patient.

      The amount of fluid to be withdrawn to the patient, the ultrafiltration rate and the duration
      time are determined by the nephrologist physician in consultation prior to the HD session.
      Such information may be modified in the HD session depending on the clinical evaluation of
      the patient on the day of treatment.

      Before starting HD, the patient's vascular access is prepared with three alcohol times and
      three times of 10% EXSEPT, and the clot is removed from the access.

      The time, ultrafiltration rate and the amount of liquid to be filtered on the HD machine
      (Fresenius Medical Care 4008 S - OCM Kt / V) are then programmed. Once programmed, it
      connects To the patient and heparin is administered at an initial bolus and at each hour of
      treatment. A total of 100 units per kg of body weight is given and the total is divided
      between the initial bolus and each hour of treatment. The mechanism by which the HD machine
      works is as follows: A pump directs the patient's blood to a filter of Polysulfone fibers,
      blood runs up-down, while a dialysing solution (its content is similar to normal blood
      plasma) flows in the opposite direction. By means of osmosis and the pressure exerted by the
      filter, excess substances are removed from the patient's blood and, if any of the plasma
      components are deficient, is absorbed from the dialysing solution. The blood is returned to
      the patient and heparin is supplied at both catheter outlets to avoid coagulation. The
      catheter is then sealed with a stopper and a patch is placed to prevent contact with the
      outside medium. Finally, the vital signs are reviewed again and the appointment is scheduled
      for the next treatment. In case the vital signs are altered, the patient is immediately
      referred to the emergency department.

        -  Laboratory parameters: Pre and post-dialysis patient blood samples will be taken to
           analyze the following parameters: serum electrolytes, blood biometrics, blood chemistry
           and Hepatic function. If feasible, the PCR will be analyzed.

        -  Blood pressure: Blood pressure will be measured with an automatic monitor included in
           the hemodialysis equipment (Fresenius Medical Care 4008 S - OCM Kt / V). To perform the
           measurement, the patient has to be relaxed and seated comfortably, at a comfortable
           ambient temperature. Do not bathe, drink alcohol or caffeine, smoke, exercise or eat 30
           minutes before taking the measurement. The participants should sit in a chair with their
           feet flat on the floor, the back straight and the arm band should be at the same level
           as their heart with the palm up and relaxed. The nurse will start by palpating the arm
           for the pulse of the brachial artery, where the diaphragm of the stethoscope will be
           placed. This artery is located between the brachial and brachial biceps muscles; In its
           lower-lateral path accompanies the median nerve. The bracelet should be placed to take
           the measurement.Special considerations: - In patients with peripheral insertion of
           central catheters, the upper arm should be avoided in which there is a central
           peripheral insertion catheter. - In patients with a bypass Dialysis, or fistula, blood
           pressure should be taken in the opposite arm if the patient has an arteriovenous
           insertion or fistula necessary for dialysis, this is to avoid possible trauma or clot
           formation.

        -  Nutritional intervention: Patients will be made aware of the importance of adherence to
           nutritional treatment through individualized sessions, addressing the following topics:
           a) how to ensure adequate energy and protein intake, b) how to control fluid, sodium and
           potassium intake, identifying foods rich in them, c) Incorrect feeding, d) food
           preparation techniques, among others. Also, in each session, depending on the patient's
           nutritional status, laboratory values and comorbidities, a personalized feeding guide
           will be provided, which will include the foods to be consumed and in what quantities,
           using the Mexican equivalents system for renal patients and the current Kidney Disease
           Improving Global Outcomes (KDIGO) practice guidelines.

        -  Malnutrition Inflammation Score (MIS), Bilbrey Index and subjective global assessment:
           These are instruments that will be used to establish a Nutritional diagnosis of each
           patient. Clinical, biochemical and anthropometric parameters are evaluated. Each of the
           measurements will be made according to the current standardized methodology.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Non-randomized pre-test / post-test clinical trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from Baseline Systolic Blood Pressure at 6 months
time frame: 6 months
description: (mm Hg)
measure: Change from Baseline Dry weight at 6 months
time frame: 6 months
description: (Kg)
measure: Height
time frame: 6 months
description: Meters
measure: Change from Baseline Tricep skinfold at 6 months
time frame: 6 months
description: mm
measure: Elbow width
time frame: 6 months
description: cm
measure: Change from Baseline Arm circumference at 6 months
time frame: 6 months
description: cm
measure: Change from Baseline Dynamometry at 6 months
time frame: 6 months
description: Kg
measure: Change from Baseline Seric glucose at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Seric cholesterol at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Seric creatinine at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Total proteins at 6 months
time frame: 6 months
description: g/dL
measure: Change from Baseline Albumin at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Pre-albumin at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Blood urea nitrogen at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Reactive C protein at 6 months
time frame: 6 months
description: mg/L
measure: Change from Baseline Chloride at 6 months
time frame: 6 months
description: meq/L
measure: Sodium
time frame: 6 months
description: meq/L
measure: Change from Baseline Potassium at 6 months
time frame: 6 months
description: meq/L
measure: Change from Baseline Calcium at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Magnesium at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Phosphorus at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Transferrin at 6 months
time frame: 6 months
description: mg/dL
measure: Change from Baseline Lymphocytes at 6 months
time frame: 6 months
measure: Change from Baseline Leukocytes at 6 months
time frame: 6 months
description: (10^3)/uL
measure: Change from Baseline Single frequency bioimpedance at 6 months
time frame: 6 months
description: Resistance and Reactance
measure: Change from Baseline Nutritional Status at 6 months
time frame: 6 months
description: Bilbrey Index (BI)
measure: Change from Baseline Extracellular water at 6 months
time frame: 6 months
description: (Liters)
measure: Change from Baseline Nutritional Status at 6 months
time frame: 6 months
description: Subjective Global Assessment (SGA)
measure: Change from Baseline Nutritional Status at 6 months
time frame: 6 months
description: Malnutrition-Inflammation Score (MIS)
arm group label: Intervention group
arm group type: Experimental
description: Evaluation,estimation and modification of the dry weight by BIVA.
intervention type: Combination Product
intervention name: To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA
description: Using the BIVA method, excess fluid will be estimated in patients with chronic renal failure undergoing hemodialysis in order to obtain a better estimate of dry weight and thus improve the quality of life of patients.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mauro Eduardo Valencia Juillerat, P.H.D.
role: Principal Investigator
affiliation: Universidad de Sonora
facility: 
country: Mexico
url: https://www.kidney.org/professionals/guidelines
description: The National Kidney Foundation produces clinical practice guidelines through the NKF Kidney Disease Outcomes Quality Initiative (NKF KDOQI)™. This program has provided evidence-based guidelines for all stages of chronic kidney disease (CKD)
citation: Lavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011.
citation: Bekheirnia MR, Schrier RW. Pathophysiology of water and sodium retention: edematous states with normal kidney function. Curr Opin Pharmacol. 2006 Apr;6(2):202-7. doi: 10.1016/j.coph.2005.09.008. Epub 2006 Feb 17.
PMID: 16483846
citation: Chaney E, Shaw A. Pathophysiology of fluid retention in heart failure. Contrib Nephrol. 2010;164:46-53. doi: 10.1159/000313720. Epub 2010 Apr 20.
PMID: 20427993
citation: Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063.
PMID: 12953039
citation: Muldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6.
citation: Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. Am Fam Physician. 2013 Jul 15;88(2):102-10.
PMID: 23939641
citation: Casey G. Oedema: causes, physiology and nursing management. Nurs Stand. 2004 Sep 1-7;18(51):45-51; quiz 52. doi: 10.7748/ns.18.51.45.s54.
PMID: 15487497
citation: Cameron N. Essential anthropometry: Baseline anthropometric methods for human biologists in laboratory and field situations. Am J Hum Biol. 2013 May-Jun;25(3):291-9. doi: 10.1002/ajhb.22388. No abstract available.
PMID: 23606226
citation: National Institute for Health and Care Excellence (NICE). The BCM - Body Composition Monitor for managing fluid in people having dialysis. Medtech innovation briefing. Published: 13 October 2015
citation: Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for physical therapists. Cardiopulm Phys Ther J. 2011 Jun;22(2):5-12.
PMID: 21637392
citation: Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009
citation: Piccoli A, Nescolarde LD, Rosell J. [Conventional and vectorial analysis of bioimpedance in clinical practice]. Nefrologia. 2002;22(3):228-38. No abstract available. Spanish.
PMID: 12123122
citation: NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994. Nutrition. 1996 Nov-Dec;12(11-12):749-62.
PMID: 8974099
citation: Jian Y, Li X, Cheng X, Chen Y, Liu L, Tao Z, Zuo L. Comparison of bioimpedance and clinical methods for dry weight prediction in maintenance hemodialysis patients. Blood Purif. 2014;37(3):214-20. doi: 10.1159/000362109. Epub 2014 Jun 5.
PMID: 24902760
citation: Hyun SH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Assessment of fluid and nutritional status using multifrequency bioelectrical impedance analysis in peritoneal dialysis patients. Blood Purif. 2014;37(2):152-62. doi: 10.1159/000360272. Epub 2014 Apr 26.
PMID: 24777057
citation: Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
PMID: 23732715
citation: Atilano-Carsi X, Miguel JL, Martinez Ara J, Sanchez Villanueva R, Gonzalez Garcia E, Selgas Gutierrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1;31(5):2220-9. doi: 10.3305/nh.2015.31.5.8649. Spanish.
PMID: 25929397
citation: Espinosa-Cuevas Mde L, Rivas-Rodriguez L, Gonzalez-Medina EC, Atilano-Carsi X, Miranda-Alatriste P, Correa-Rotter R. [Bioimpedance vector analysis for body composition in Mexican population]. Rev Invest Clin. 2007 Jan-Feb;59(1):15-24. Spanish.
PMID: 17569296
citation: Espinosa Cuevas MA, Navarrete Rodriguez G, Villeda Martinez ME, Atilano Carsi X, Miranda Alatriste P, Tostado Gutierrez T, Correa-Rotter R. Body fluid volume and nutritional status in hemodialysis: vector bioelectric impedance analysis. Clin Nephrol. 2010 Apr;73(4):300-8.
PMID: 20353738
citation: Gonzalez-Ortiz AJ, Arce-Santander CV, Vega-Vega O, Correa-Rotter R, Espinosa-Cuevas Mde L. Assessment of the reliability and consistency of the "malnutrition inflammation score" (MIS) in Mexican adults with chronic kidney disease for diagnosis of protein-energy wasting syndrome (PEW). Nutr Hosp. 2014 Oct 4;31(3):1352-8. doi: 10.3305/nh.2015.31.3.8173.
PMID: 25726233
responsible party type: Principal Investigator
investigator affiliation: Universidad de Sonora
investigator full name: Mauro Eduardo Valencia Juillerat
investigator title: P.H.D. Principal researcher
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency, Chronic
mesh term: Body Weight
sharing ipd: Undecided