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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Evaluation,estimation and modification of the dry weight by BIVA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Systolic Blood Pressure at 6 months | (mm Hg) | 6 months |
| Change from Baseline Dry weight at 6 months | (Kg) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Meters | 6 months |
| Change from Baseline Tricep skinfold at 6 months | mm | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Eduardo Valencia Juillerat, P.H.D. | Universidad de Sonora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours" | Hermosillo | Sonora | 83000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lavilla Royo FJ. Protocolo diagnóstico de los edemas. Medicine 10(79):5379-82, 2011. | ||
| 16483846 | Background | 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. | |
| 20427993 |
| Label | URL |
|---|---|
| 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) | View source |
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Non-randomized pre-test / post-test clinical trial
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|
| Elbow width | cm | 6 months |
| Change from Baseline Arm circumference at 6 months | cm | 6 months |
| Change from Baseline Dynamometry at 6 months | Kg | 6 months |
| Change from Baseline Seric glucose at 6 months | mg/dL | 6 months |
| Change from Baseline Seric cholesterol at 6 months | mg/dL | 6 months |
| Change from Baseline Seric creatinine at 6 months | mg/dL | 6 months |
| Change from Baseline Total proteins at 6 months | g/dL | 6 months |
| Change from Baseline Albumin at 6 months | mg/dL | 6 months |
| Change from Baseline Pre-albumin at 6 months | mg/dL | 6 months |
| Change from Baseline Blood urea nitrogen at 6 months | mg/dL | 6 months |
| Change from Baseline Reactive C protein at 6 months | mg/L | 6 months |
| Change from Baseline Chloride at 6 months | meq/L | 6 months |
| Sodium | meq/L | 6 months |
| Change from Baseline Potassium at 6 months | meq/L | 6 months |
| Change from Baseline Calcium at 6 months | mg/dL | 6 months |
| Change from Baseline Magnesium at 6 months | mg/dL | 6 months |
| Change from Baseline Phosphorus at 6 months | mg/dL | 6 months |
| Change from Baseline Transferrin at 6 months | mg/dL | 6 months |
| Change from Baseline Lymphocytes at 6 months | 6 months |
| Change from Baseline Leukocytes at 6 months | (10^3)/uL | 6 months |
| Change from Baseline Single frequency bioimpedance at 6 months | Resistance and Reactance | 6 months |
| Change from Baseline Nutritional Status at 6 months | Bilbrey Index (BI) | 6 months |
| Change from Baseline Extracellular water at 6 months | (Liters) | 6 months |
| Change from Baseline Nutritional Status at 6 months | Subjective Global Assessment (SGA) | 6 months |
| Change from Baseline Nutritional Status at 6 months | Malnutrition-Inflammation Score (MIS) | 6 months |
| Background |
| 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. |
| 12953039 | Background | Koomans HA. Pathophysiology of oedema in idiopathic nephrotic syndrome. Nephrol Dial Transplant. 2003 Aug;18 Suppl 6:vi30-2. doi: 10.1093/ndt/gfg1063. |
| Background | Muldoon J. Assessment and monitoring of oedema. Journal of Community Nursing. November/December 2011, volume 25, issue 6. |
| 23939641 | Background | Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. Am Fam Physician. 2013 Jul 15;88(2):102-10. |
| 15487497 | Background | 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. |
| 23606226 | Background | 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. |
| 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 |
| 21637392 | Background | Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for physical therapists. Cardiopulm Phys Ther J. 2011 Jun;22(2):5-12. |
| Background | Perez Lizaur, Palacios González. Sistema Mexicano de Equivalentes para Paciente Renal. Fomento de Nutrición y Salud. México D.F, julio 2009 |
| 12123122 | 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. |
| 8974099 | 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. |
| 24902760 | Result | 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. |
| 24777057 | 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. |
| 23732715 | 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. |
| 25929397 | 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. |
| 17569296 | 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. |
| 20353738 | 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. |
| 25726233 | 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. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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