AzTrials
AzTrials

Chronic Renal FailureNCT03232515

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

A study testing To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA in people with Chronic Renal Failure and Dialysis, run by Universidad de Sonora at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Renal Failure, Dialysis, Dry Weight
What is being tested?
To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteMexico
Study dates
7 Aug 2017to 7 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours"

    Hermosillo, Sonora, 83000

Other trials in Mexico

About this study

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.

Read more

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.

Read the detailed description
  • 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.
Being tested
To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA
Keywords
Bioimpedance Vector Analysis (BIVA), Chronic Renal Failure, Dialysis, Dry weight, Blood Pressure
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVACombination 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.

Study groups in NCT03232515
Study groupRoleWhat they receive
Intervention groupExperimentalEvaluation,estimation and modification of the dry weight by BIVA.
Receives: Combination Product: To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Systolic Blood Pressure at 6 months

    (mm Hg)

    Measured: 6 months

  2. Change from Baseline Dry weight at 6 months

    (Kg)

    Measured: 6 months

Secondary outcomes (27)
  1. Height

    Meters

    Measured: 6 months

  2. Change from Baseline Tricep skinfold at 6 months

    mm

    Measured: 6 months

  3. Elbow width

    cm

    Measured: 6 months

  4. Change from Baseline Arm circumference at 6 months

    cm

    Measured: 6 months

  5. Change from Baseline Dynamometry at 6 months

    Kg

    Measured: 6 months

  6. Change from Baseline Seric glucose at 6 months

    mg/dL

    Measured: 6 months

  7. Change from Baseline Seric cholesterol at 6 months

    mg/dL

    Measured: 6 months

  8. Change from Baseline Seric creatinine at 6 months

    mg/dL

    Measured: 6 months

  9. Change from Baseline Total proteins at 6 months

    g/dL

    Measured: 6 months

  10. Change from Baseline Albumin at 6 months

    mg/dL

    Measured: 6 months

  11. Change from Baseline Pre-albumin at 6 months

    mg/dL

    Measured: 6 months

  12. Change from Baseline Blood urea nitrogen at 6 months

    mg/dL

    Measured: 6 months

  13. Change from Baseline Reactive C protein at 6 months

    mg/L

    Measured: 6 months

  14. Change from Baseline Chloride at 6 months

    meq/L

    Measured: 6 months

  15. Sodium

    meq/L

    Measured: 6 months

  16. Change from Baseline Potassium at 6 months

    meq/L

    Measured: 6 months

  17. Change from Baseline Calcium at 6 months

    mg/dL

    Measured: 6 months

  18. Change from Baseline Magnesium at 6 months

    mg/dL

    Measured: 6 months

  19. Change from Baseline Phosphorus at 6 months

    mg/dL

    Measured: 6 months

  20. Change from Baseline Transferrin at 6 months

    mg/dL

    Measured: 6 months

  21. Change from Baseline Lymphocytes at 6 months

    Measured: 6 months

  22. Change from Baseline Leukocytes at 6 months

    (10^3)/uL

    Measured: 6 months

  23. Change from Baseline Single frequency bioimpedance at 6 months

    Resistance and Reactance

    Measured: 6 months

  24. Change from Baseline Nutritional Status at 6 months

    Bilbrey Index (BI)

    Measured: 6 months

  25. Change from Baseline Extracellular water at 6 months

    (Liters)

    Measured: 6 months

  26. Change from Baseline Nutritional Status at 6 months

    Subjective Global Assessment (SGA)

    Measured: 6 months

  27. Change from Baseline Nutritional Status at 6 months

    Malnutrition-Inflammation Score (MIS)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2017
  2. Study start7 Aug 2017
  3. Primary completion7 Feb 2018
  4. Study completion7 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Non-randomized pre-test / post-test clinical trial
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03232515
Sponsor's protocol ID
DMCS/CBIDMCS/D-87bis
Status last verified
Nov 2018
First submitted
14 Jul 2017
Last updated
29 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011.

  • 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.

    PubMed 16483846
  • 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.

    PubMed 20427993
  • Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063.

    PubMed 12953039
  • Muldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6.

  • Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. Am Fam Physician. 2013 Jul 15;88(2):102-10.

    PubMed 23939641
  • 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.

    PubMed 15487497
  • 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.

    PubMed 23606226
  • 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

  • Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for physical therapists. Cardiopulm Phys Ther J. 2011 Jun;22(2):5-12.

    PubMed 21637392
  • Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009

  • 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.

    PubMed 12123122
  • 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.

    PubMed 8974099
  • 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.

    PubMed 24902760
  • 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.

    PubMed 24777057

Questions about this trial

What is this clinical trial studying?

A study testing To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA in people with Chronic Renal Failure and Dialysis, run by Universidad de Sonora at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Systolic Blood Pressure at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232515, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in