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The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis

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ClinicalTrials.gov Identifier: NCT03232515
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Renal Failure Dialysis Dry Weight Blood Pressure Combination Product: To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized pre-test / post-test clinical trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : February 7, 2018
Estimated Study Completion Date : August 7, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention group
Evaluation,estimation and modification of the dry weight by BIVA.
Combination Product: To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Systolic Blood Pressure at 6 months [ Time Frame: 6 months ]
    (mm Hg)

  2. Change from Baseline Dry weight at 6 months [ Time Frame: 6 months ]
    (Kg)


Secondary Outcome Measures :
  1. Height [ Time Frame: 6 months ]
    Meters

  2. Change from Baseline Tricep skinfold at 6 months [ Time Frame: 6 months ]
    mm

  3. Elbow width [ Time Frame: 6 months ]
    cm

  4. Change from Baseline Arm circumference at 6 months [ Time Frame: 6 months ]
    cm

  5. Change from Baseline Dynamometry at 6 months [ Time Frame: 6 months ]
    Kg

  6. Change from Baseline Seric glucose at 6 months [ Time Frame: 6 months ]
    mg/dL

  7. Change from Baseline Seric cholesterol at 6 months [ Time Frame: 6 months ]
    mg/dL

  8. Change from Baseline Seric creatinine at 6 months [ Time Frame: 6 months ]
    mg/dL

  9. Change from Baseline Total proteins at 6 months [ Time Frame: 6 months ]
    g/dL

  10. Change from Baseline Albumin at 6 months [ Time Frame: 6 months ]
    mg/dL

  11. Change from Baseline Pre-albumin at 6 months [ Time Frame: 6 months ]
    mg/dL

  12. Change from Baseline Blood urea nitrogen at 6 months [ Time Frame: 6 months ]
    mg/dL

  13. Change from Baseline Reactive C protein at 6 months [ Time Frame: 6 months ]
    mg/L

  14. Change from Baseline Chloride at 6 months [ Time Frame: 6 months ]
    meq/L

  15. Sodium [ Time Frame: 6 months ]
    meq/L

  16. Change from Baseline Potassium at 6 months [ Time Frame: 6 months ]
    meq/L

  17. Change from Baseline Calcium at 6 months [ Time Frame: 6 months ]
    mg/dL

  18. Change from Baseline Magnesium at 6 months [ Time Frame: 6 months ]
    mg/dL

  19. Change from Baseline Phosphorus at 6 months [ Time Frame: 6 months ]
    mg/dL

  20. Change from Baseline Transferrin at 6 months [ Time Frame: 6 months ]
    mg/dL

  21. Change from Baseline Lymphocytes at 6 months [ Time Frame: 6 months ]
  22. Change from Baseline Leukocytes at 6 months [ Time Frame: 6 months ]
    (10^3)/uL

  23. Change from Baseline Single frequency bioimpedance at 6 months [ Time Frame: 6 months ]
    Resistance and Reactance

  24. Change from Baseline Nutritional Status at 6 months [ Time Frame: 6 months ]
    Bilbrey Index (BI)

  25. Change from Baseline Extracellular water at 6 months [ Time Frame: 6 months ]
    (Liters)

  26. Change from Baseline Nutritional Status at 6 months [ Time Frame: 6 months ]
    Subjective Global Assessment (SGA)

  27. Change from Baseline Nutritional Status at 6 months [ Time Frame: 6 months ]
    Malnutrition-Inflammation Score (MIS)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be patient of the Hospital
  • Diagnosed with chronic renal failure (KDOQI stage 5)
  • >18 years
  • Undergoing Hemodialysis treatment

Exclusion Criteria:

  • Amputations
  • Have metalic implants
  • Have pacemaker
  • Renal transplant (or in protocol to receive it)
  • Infectious processes
Contacts and Locations

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): NCT03232515


Contacts
Contact: Mauro Eduardo Valencia Juillerat, P.H.D. (+52) 6621 110786 mauro@ciad.mx
Contact: Erika Nallely Ibarra Pastrana, M.Sc. (+52) 6621 005997 erika.pastrana@hotmail.com

Locations
Mexico
Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours" Recruiting
Hermosillo, Sonora, Mexico, 83000
Contact: Erika N Ibarra Pastrana, M.Sc.    (+52) 6621 005997    erika.pastrana@hotmail.com   
Sponsors and Collaborators
Universidad de Sonora
Investigators
Principal Investigator: Mauro Eduardo Valencia Juillerat, P.H.D. Universidad de Sonora
More Information

Additional Information:
Publications:
Lavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011.
Muldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6.
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
Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009

Responsible Party: Mauro Eduardo Valencia Juillerat, P.H.D. Principal researcher, Universidad de Sonora
ClinicalTrials.gov Identifier: NCT03232515     History of Changes
Other Study ID Numbers: DMCS/CBIDMCS/D-87bis
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mauro Eduardo Valencia Juillerat, Universidad de Sonora:
Bioimpedance Vector Analysis (BIVA)
Chronic Renal Failure
Dialysis
Dry weight
Blood Pressure

Additional relevant MeSH terms:
Body Weight
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Signs and Symptoms
Kidney Diseases
Urologic Diseases