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.
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
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.
- Conditions
- Chronic Renal Failure, Dialysis, Dry Weight, Blood Pressure
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Evaluation,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.
Change from Baseline Systolic Blood Pressure at 6 months
(mm Hg)
Measured: 6 months
Change from Baseline Dry weight at 6 months
(Kg)
Measured: 6 months
Secondary outcomes (27)
Height
Meters
Measured: 6 months
Change from Baseline Tricep skinfold at 6 months
mm
Measured: 6 months
Elbow width
cm
Measured: 6 months
Change from Baseline Arm circumference at 6 months
cm
Measured: 6 months
Change from Baseline Dynamometry at 6 months
Kg
Measured: 6 months
Change from Baseline Seric glucose at 6 months
mg/dL
Measured: 6 months
Change from Baseline Seric cholesterol at 6 months
mg/dL
Measured: 6 months
Change from Baseline Seric creatinine at 6 months
mg/dL
Measured: 6 months
Change from Baseline Total proteins at 6 months
g/dL
Measured: 6 months
Change from Baseline Albumin at 6 months
mg/dL
Measured: 6 months
Change from Baseline Pre-albumin at 6 months
mg/dL
Measured: 6 months
Change from Baseline Blood urea nitrogen at 6 months
mg/dL
Measured: 6 months
Change from Baseline Reactive C protein at 6 months
mg/L
Measured: 6 months
Change from Baseline Chloride at 6 months
meq/L
Measured: 6 months
Sodium
meq/L
Measured: 6 months
Change from Baseline Potassium at 6 months
meq/L
Measured: 6 months
Change from Baseline Calcium at 6 months
mg/dL
Measured: 6 months
Change from Baseline Magnesium at 6 months
mg/dL
Measured: 6 months
Change from Baseline Phosphorus at 6 months
mg/dL
Measured: 6 months
Change from Baseline Transferrin at 6 months
mg/dL
Measured: 6 months
Change from Baseline Lymphocytes at 6 months
Measured: 6 months
Change from Baseline Leukocytes at 6 months
(10^3)/uL
Measured: 6 months
Change from Baseline Single frequency bioimpedance at 6 months
Resistance and Reactance
Measured: 6 months
Change from Baseline Nutritional Status at 6 months
Bilbrey Index (BI)
Measured: 6 months
Change from Baseline Extracellular water at 6 months
(Liters)
Measured: 6 months
Change from Baseline Nutritional Status at 6 months
Subjective Global Assessment (SGA)
Measured: 6 months
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.
- First posted28 Jul 2017
- Study start7 Aug 2017
- Primary completion7 Feb 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Eduardo Valencia Juillerat, Universidad de Sonora
- Investigators
- Mauro Eduardo Valencia Juillerat, P.H.D., Principal investigator, Universidad de Sonora
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 16483846Chaney 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 20427993Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063.
PubMed 12953039Muldoon 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 23939641Casey 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 15487497Cameron 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 23606226National 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 21637392Perez 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 12123122NIH 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 8974099Jian 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 24902760Hyun 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis
- ClinicalTrials.gov ID
- NCT03232515
- Acronym / sponsor ID
- DMCS/CBIDMCS/D-87bis
- Conditions
- Chronic Renal Failure, Dialysis, Dry Weight, Blood Pressure
- Keywords
- Bioimpedance Vector Analysis (BIVA), Chronic Renal Failure, Dialysis, Dry weight, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized pre-test / post-test clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVAEvaluation,estimation and modification of the dry weight by BIVA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be patient of the Hospital
- Diagnosed with chronic renal failure (KDOQI stage 5)
- >18 years
- Undergoing Hemodialysis treatment
Key exclusion criteria (5 listed)
- Amputations
- Have metalic implants
- Have pacemaker
- Renal transplant (or in protocol to receive it)
- Infectious processes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVAUsing 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. | Combination product | Intervention group |
Primary outcome
Change from Baseline Systolic Blood Pressure at 6 months
Time frame: 6 months
(mm Hg)
Change from Baseline Dry weight at 6 months
Time frame: 6 months
(Kg)
27 secondary outcomes
Height
Time frame: 6 months
Change from Baseline Tricep skinfold at 6 months
Time frame: 6 months
Elbow width
Time frame: 6 months
Change from Baseline Arm circumference at 6 months
Time frame: 6 months
Change from Baseline Dynamometry at 6 months
Time frame: 6 months
Change from Baseline Seric glucose at 6 months
Time frame: 6 months
Change from Baseline Seric cholesterol at 6 months
Time frame: 6 months
Change from Baseline Seric creatinine at 6 months
Time frame: 6 months
Change from Baseline Total proteins at 6 months
Time frame: 6 months
Change from Baseline Albumin at 6 months
Time frame: 6 months
Change from Baseline Pre-albumin at 6 months
Time frame: 6 months
Change from Baseline Blood urea nitrogen at 6 months
Time frame: 6 months
Change from Baseline Reactive C protein at 6 months
Time frame: 6 months
Change from Baseline Chloride at 6 months
Time frame: 6 months
Sodium
Time frame: 6 months
Change from Baseline Potassium at 6 months
Time frame: 6 months
Change from Baseline Calcium at 6 months
Time frame: 6 months
Change from Baseline Magnesium at 6 months
Time frame: 6 months
Change from Baseline Phosphorus at 6 months
Time frame: 6 months
Change from Baseline Transferrin at 6 months
Time frame: 6 months
Change from Baseline Lymphocytes at 6 months
Time frame: 6 months
Change from Baseline Leukocytes at 6 months
Time frame: 6 months
Change from Baseline Single frequency bioimpedance at 6 months
Time frame: 6 months
Change from Baseline Nutritional Status at 6 months
Time frame: 6 months
Change from Baseline Extracellular water at 6 months
Time frame: 6 months
Change from Baseline Nutritional Status at 6 months
Time frame: 6 months
Change from Baseline Nutritional Status at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- BackgroundLavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011.
- Background: PubMed 16483846Bekheirnia 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.
- Background: PubMed 20427993Chaney E, Shaw A. Pathophysiology of fluid retention in heart failure. Contrib Nephrol. 2010;164:46-53. doi: 10.1159/000313720. Epub 2010 Apr 20.
- Background: PubMed 12953039Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063.
- BackgroundMuldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6.
- Background: PubMed 23939641Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. Am Fam Physician. 2013 Jul 15;88(2):102-10.
- Background: PubMed 15487497Casey 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.
- Background: PubMed 23606226Cameron 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.
- BackgroundNational 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: PubMed 21637392Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for physical therapists. Cardiopulm Phys Ther J. 2011 Jun;22(2):5-12.
- BackgroundPerez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009
- Background: PubMed 12123122Piccoli A, Nescolarde LD, Rosell J. [Conventional and vectorial analysis of bioimpedance in clinical practice]. Nefrologia. 2002;22(3):228-38. No abstract available. Spanish.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Eduardo Valencia Juillerat, P.H.D. principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
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.