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

NCT03232515 | Completed DMC

• 1 other identifier: DMCS/CBIDMCS/D-87bis
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure; Dialysis; Dry Weight; Blood Pressure

Keywords

Bioimpedance Vector Analysis (BIVA); Chronic Renal Failure; Dialysis; Dry weight; Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Systolic Blood Pressure at 6 months

  (mm Hg)

  6 months

• Change from Baseline Dry weight at 6 months

  (Kg)

  6 months

Secondary Outcomes (27)

• Height

  6 months

• Change from Baseline Tricep skinfold at 6 months

  6 months

• Elbow width

  6 months

• Change from Baseline Arm circumference at 6 months

  6 months

• Change from Baseline Dynamometry at 6 months

  6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA COMBINATION_PRODUCT

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours"

Hermosillo, Sonora, 83000, Mexico

Location

Related Publications (20)

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  BACKGROUND

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  PMID: 16483846 BACKGROUND

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  PMID: 12953039 BACKGROUND

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  BACKGROUND

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  PMID: 23939641 BACKGROUND

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  PMID: 15487497 BACKGROUND

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  PMID: 23606226 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• 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)

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauro Eduardo Valencia Juillerat, P.H.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.H.D. Principal researcher

Model Details: Non-randomized pre-test / post-test clinical trial

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 28, 2017
• Study Start: August 7, 2017
• Primary Completion: February 7, 2018
• Study Completion: August 7, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

ME (1)