Blood Pressure Clinical Trial
Official title:
The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis
Verified date | November 2018 |
Source | Universidad de Sonora |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 7, 2018 |
Est. primary completion date | February 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Must be patient of the Hospital - Diagnosed with chronic renal failure (KDOQI stage 5) - >18 years - Undergoing Hemodialysis treatment Exclusion Criteria: - Amputations - Have metalic implants - Have pacemaker - Renal transplant (or in protocol to receive it) - Infectious processes |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General del Estado de Sonora "Dr. Ernesto Ramos Bours" | Hermosillo | Sonora |
Lead Sponsor | Collaborator |
---|---|
Universidad de Sonora |
Mexico,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Systolic Blood Pressure at 6 months | (mm Hg) | 6 months | |
Primary | Change from Baseline Dry weight at 6 months | (Kg) | 6 months | |
Secondary | Height | Meters | 6 months | |
Secondary | Change from Baseline Tricep skinfold at 6 months | mm | 6 months | |
Secondary | Elbow width | cm | 6 months | |
Secondary | Change from Baseline Arm circumference at 6 months | cm | 6 months | |
Secondary | Change from Baseline Dynamometry at 6 months | Kg | 6 months | |
Secondary | Change from Baseline Seric glucose at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Seric cholesterol at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Seric creatinine at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Total proteins at 6 months | g/dL | 6 months | |
Secondary | Change from Baseline Albumin at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Pre-albumin at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Blood urea nitrogen at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Reactive C protein at 6 months | mg/L | 6 months | |
Secondary | Change from Baseline Chloride at 6 months | meq/L | 6 months | |
Secondary | Sodium | meq/L | 6 months | |
Secondary | Change from Baseline Potassium at 6 months | meq/L | 6 months | |
Secondary | Change from Baseline Calcium at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Magnesium at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Phosphorus at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Transferrin at 6 months | mg/dL | 6 months | |
Secondary | Change from Baseline Lymphocytes at 6 months | 6 months | ||
Secondary | Change from Baseline Leukocytes at 6 months | (10^3)/uL | 6 months | |
Secondary | Change from Baseline Single frequency bioimpedance at 6 months | Resistance and Reactance | 6 months | |
Secondary | Change from Baseline Nutritional Status at 6 months | Bilbrey Index (BI) | 6 months | |
Secondary | Change from Baseline Extracellular water at 6 months | (Liters) | 6 months | |
Secondary | Change from Baseline Nutritional Status at 6 months | Subjective Global Assessment (SGA) | 6 months | |
Secondary | Change from Baseline Nutritional Status at 6 months | Malnutrition-Inflammation Score (MIS) | 6 months |
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