Ainshams university
Cairo, Egypt, 11111
NCT Number: NCT07765459
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Cairo, Egypt, 11111
Inclusion criteria
Exclusion criteria
patients with the following will be excluded from the study
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
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
oral sodium bicarbonate to correct interdialytic metabolic acidosis
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
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
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
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
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
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.
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
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
Ain Shams University
Other
The Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Prevalent Hemodialysis Patients
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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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