the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
* Type of Study: Prospective randomized interventional study using simple randomization ( even and odd number method ) * Study Settings: Ain Shams University hospital hemodialysis unit , Cairo, Egypt. * Study period: 6 months. Inclusion Criteria: * Adult prevalent hemodialysis patients on regular hemodialysis more than 6 months , three sessions per week of four hours duration * Patients with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study. Exclusion Criteria: patients with the following will be excluded from the study * Patients with hemodialysis catheters * Patients with active inflammation , infection or active malignancy * Patients with history of parathyroidectomy * Patients with other organ failure such as decompensated heart failure or liver cell failure * Study Population: Adult patients on regular hemodialysis with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study. * Sample size: 20 ESRD patients who had been on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months 20 ESRD patients on regular hemodialysis with serum bicarbonate levels ≤22 for at least 6 months as control matched in age and sex all patients will be subjected to the following: 1. Full history taking. 2. General and local examination. C-Laboratory investigations . The following parameters will be assessed before and after correction of acidosis: total serum calcium, serum albumin , plasma phosphate, iPTH, serum bicarbonate concentration, hemoglobin,. parameters will be drawn at the start of the dialysis session after the long dialysis interval Patients will be studied both before (pre) and at the end of (post) 6 months of correction of their metabolic acidosis by oral supplementation with sodium bicarbonate mean dose 1-3 g/day . Serum bicarbonate levels during correction will be maintained between 22 and 28 mmol/l . serum bicarbonate level will be withdrawn monthly and if the patients Hco3 during the monthly follow up exceeds 28 mmol/l , the dose of sodium bicarbonate will be withheld and we will follow up the serum bicarbonate level one month later . Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end Imaging : carotid artery duplex will be done to all patients at the start of the study and at the end
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
oral sodium bicarbonate to correct interdialytic metabolic acidosis
Ainshams university
Cairo, Egypt, Egypt
correction of acidosis and its effect on vascular calcification
change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters
Time frame: 6 months
Change in Serum Calcium Level
Serum calcium will be measured from blood samples at baseline and at the end of the study. The change in serum calcium level from baseline to the end of the study will be assessed.Unit of Measure: mg/dL
Time frame: 6 months
Change in Serum Phosphorus Level
Serum phosphorus will be measured from blood samples at baseline and at the end of the study. The change in serum phosphorus level from baseline to the end of the study will be assessed. Unit of Measure: mg/dL
Time frame: 6 months
Change in Intact Parathyroid Hormone (iPTH) Level
Serum intact parathyroid hormone (iPTH) will be measured from blood samples at baseline and at the end of the study. The change in iPTH level from baseline to the end of the study will be assessed. Unit of Measure: pg/mL
Time frame: 6 months
Change in Hemoglobin Concentration
Hemoglobin concentration will be measured from blood samples at baseline and at the end of the study. The change in hemoglobin concentration from baseline to the end of the study will be assessed . Unit of Measure: g/dL
Time frame: 6 months
Change in Serum Albumin Level
Serum albumin will be measured from blood samples at baseline and at the end of the study. The change in serum albumin level from baseline to the end of the study will be assessed.
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Time frame: Unit of Measure: g/dL
Change in Venous Blood pH
Venous blood pH will be measured at baseline and at the end of the study. The change in venous blood pH from baseline to the end of the study will be assessed. Unit of Measure: pH units
Time frame: 6 months
Change in Serum Bicarbonate Level
Serum bicarbonate will be measured from blood samples at baseline and at the end of the study. The change in serum bicarbonate level from baseline to the end of the study will be assessed. Unit of Measure: mmol/L
Time frame: 6 months