Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

November 14, 2025 updated by: Shani Zilberman Itskovich, Assaf-Harofeh Medical Center
The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
    • Is
      • Ẕerifin, Is, Israel, 70300
        • Shamir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic hemodialysis patient > 3 months
  • 3 dialysis per week, KTV>1.2
  • capable of informed concent.
  • rise in blood pressure during hemodialysis > 10 mm Hg, for at least 50% of dialysis sessions in the month prior to inclusion.
  • Normal volume status, by clinical physician assessment + bioimpedance

Exclusion Criteria:

  • age under 18,
  • pregnancy
  • unable to sign informed concent
  • planned for kidney transplant in the following 3 month.
  • congestive heart failure (NYHA 3-4)
  • hospitalization for acute MI or CHF in the past 3 months.
  • low compliece to medical therapy
  • regular pre-dialysis tests with bicarbonate > 24 in the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium bicarbonate
PO Sodium bicarbonate 500mg X2/day
Drug: Sodium Bicarbonate (NaHCO3)
Prescribing Sodium Bicaronate for intra-dualytic hypertension
Placebo Comparator: Placebo
1 tab X2/day
Drug: Placebo
1 tab X 2/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 1 month
Prevention of intra dialytic hypertension
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0208-25-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

blood pressure results, blood tests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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