End Stage Renal Disease (ESRD), Metabolic Acidosis
Conditions
Brief summary
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
Detailed description
* 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 serum bicarbonate level will be withdrawn monthly and if the patients Hco3 during the monthly follow up exceeds 28 mmol/l , the dose of sodium bicarbonate will be withheld and we will follow up the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
Interventions
oral sodium bicarbonate to correct interdialytic metabolic acidosis
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult prevalent hemodialysis patients (age 18 years or older) On regular hemodialysis for more than 6 months, with three sessions per week, each lasting four hours Metabolic acidosis at the time of recruitment, defined as a serum bicarbonate level ≤22 mmol/L for at least 6 months before the study
Exclusion criteria
Patients with hemodialysis catheters Active inflammation, infection, or active malignancy History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correction of acidosis and its effect on vascular calcification | 6 months | change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Calcium Level | 6 months | 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 |
| Change in Serum Phosphorus Level | 6 months | 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 |
| Change in Intact Parathyroid Hormone (iPTH) Level | 6 months | 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 |
| Change in Hemoglobin Concentration | 6 months | 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 |
| Change in Serum Albumin Level | Unit of Measure: g/dL | 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. |
| Change in Venous Blood pH | 6 months | 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 |
| Change in Serum Bicarbonate Level | 6 months | 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 |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAbubakr mohamed fahmy, assistant lecturer
Ain Shams University
Outcome results
None listed