Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours"
Hermosillo, Sonora, 83000, Mexico
NCT Number: NCT03232515
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hermosillo, Sonora, 83000, Mexico
The subjects should be under the following conditions so that the study can be carried out:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
(mm Hg)
Time frame: 6 months
(Kg)
Time frame: 6 months
Meters
Time frame: 6 months
mm
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cm
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cm
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Kg
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mg/dL
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g/dL
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mg/dL
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mg/dL
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mg/dL
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mg/L
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meq/L
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meq/L
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meq/L
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mg/dL
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mg/dL
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mg/dL
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(10^3)/uL
Time frame: 6 months
Resistance and Reactance
Time frame: 6 months
Bilbrey Index (BI)
Time frame: 6 months
(Liters)
Time frame: 6 months
Subjective Global Assessment (SGA)
Time frame: 6 months
Malnutrition-Inflammation Score (MIS)
Universidad de Sonora
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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