A Phase 1 interventional study of Oral sodium bicarbonate in End Stage Renal Disease (ESRD) and Metabolic Acidosis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Ain Shams University · Phase 1, Interventional, and Other
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
Inclusion Criteria:
Exclusion Criteria: patients with the following will be excluded from the study
Patients with other organ failure such as decompensated heart failure or liver cell failure
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:
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
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 40 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
this group will receive oral sodium bicabonate daily
Drug: Oral sodium bicarbonate
participants in this arm will receive standard care without bicarbonate supplementation : they will serve as the control group for comparison
oral sodium bicarbonate to correct interdialytic metabolic acidosis
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.
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Access criteria: free
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Bicarbonate