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

NCT07765459 | Completed Phase 1 DMC

• 1 other identifier: FMASU MD190/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease (ESRD); Metabolic Acidosis

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (7)

• Change in Serum Calcium Level

  6 months

• Change in Serum Phosphorus Level

  6 months

• Change in Intact Parathyroid Hormone (iPTH) Level

  6 months

• Change in Hemoglobin Concentration

  6 months

• Change in Serum Albumin Level

  Unit of Measure: g/dL

Study Arms (2)

oral sodium bicarbonate

ACTIVE COMPARATOR

this group will receive oral sodium bicabonate daily

Drug: Oral sodium bicarbonate

no intervention : control group

NO INTERVENTION

participants in this arm will receive standard care without bicarbonate supplementation : they will serve as the control group for comparison

Interventions

Oral sodium bicarbonate DRUG

oral sodium bicarbonate to correct interdialytic metabolic acidosis

oral sodium bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with hemodialysis catheters Active inflammation, infection, or active malignancy History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Acidosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Abubakr mohamed fahmy, assistant lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: August 14, 2026
• Study Start: September 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: August 14, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: free

Locations

EG (1)