The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change from Baseline Systolic Blood Pressure at 6 months
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be patient of the Hospital
- •Diagnosed with chronic renal failure (KDOQI stage 5)
- •>18 years
- •Undergoing Hemodialysis treatment
排除标准
- •Amputations
- •Have metalic implants
- •Have pacemaker
- •Renal transplant (or in protocol to receive it)
- •Infectious processes
结局指标
主要结局
Change from Baseline Systolic Blood Pressure at 6 months
时间窗: 6 months
(mm Hg)
Change from Baseline Dry weight at 6 months
时间窗: 6 months
(Kg)
次要结局
- Elbow width(6 months)
- Change from Baseline Arm circumference at 6 months(6 months)
- Change from Baseline Dynamometry at 6 months(6 months)
- Height(6 months)
- Change from Baseline Tricep skinfold at 6 months(6 months)
- Change from Baseline Albumin at 6 months(6 months)
- Change from Baseline Seric glucose at 6 months(6 months)
- Change from Baseline Pre-albumin at 6 months(6 months)
- Change from Baseline Seric cholesterol at 6 months(6 months)
- Change from Baseline Seric creatinine at 6 months(6 months)
- Change from Baseline Total proteins at 6 months(6 months)
- Sodium(6 months)
- Change from Baseline Potassium at 6 months(6 months)
- Change from Baseline Calcium at 6 months(6 months)
- Change from Baseline Phosphorus at 6 months(6 months)
- Change from Baseline Leukocytes at 6 months(6 months)
- Change from Baseline Blood urea nitrogen at 6 months(6 months)
- Change from Baseline Reactive C protein at 6 months(6 months)
- Change from Baseline Chloride at 6 months(6 months)
- Change from Baseline Magnesium at 6 months(6 months)
- Change from Baseline Transferrin at 6 months(6 months)
- Change from Baseline Lymphocytes at 6 months(6 months)
- Change from Baseline Single frequency bioimpedance at 6 months(6 months)
- Change from Baseline Extracellular water at 6 months(6 months)
- Change from Baseline Nutritional Status at 6 months(6 months)
研究者
Mauro Eduardo Valencia Juillerat
P.H.D. Principal researcher
Universidad de Sonora