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

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

Registry ID
NCT07765459
Source registry
NCT
Status
COMPLETED
Phase
PHASE1
Study type
INTERVENTIONAL
Sponsor
Ain Shams University
Enrollment
40
Start date
2023-09-01
Completion date
2024-02-29
Last update
2026-08-14

Conditions

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

Inclusion criteria

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

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

Primary outcomes

[{"measure":"correction of acidosis and its effect on vascular calcification","timeFrame":"6 months"}]

Locations

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