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Completed

NCT Number: NCT07765459

the Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Hemodialysis Patients

the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients

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Key information

About this study

  • 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:

  • Full history taking.
  • 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 serum bicarbonate level will be withdrawn monthly and if the patients Hco3 during the monthly follow up exceeds 28 mmol/l , the dose of sodium bicarbonate will be withheld and we will follow up the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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral sodium bicarbonate

Drug

oral sodium bicarbonate to correct interdialytic metabolic acidosis

Primary outcomes

  1. correction of acidosis and its effect on vascular calcification

    Time frame: 6 months

    change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters

Secondary outcomes

  1. Change in Serum Calcium Level

    Time frame: 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

  2. Change in Serum Phosphorus Level

    Time frame: 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

  3. Change in Intact Parathyroid Hormone (iPTH) Level

    Time frame: 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

  4. Change in Hemoglobin Concentration

    Time frame: 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

  5. Change in Serum Albumin Level

    Time frame: 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.

  6. Change in Venous Blood pH

    Time frame: 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

  7. Change in Serum Bicarbonate Level

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Prevalent Hemodialysis Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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