NCT07231900

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Nov 2025Dec 2027

Study Start

First participant enrolled

November 10, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Hypertension in Dialysis Patients

Keywords

Intra-dialytic hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Prevention of intra dialytic hypertension

    1 month

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

PO Sodium bicarbonate 500mg X2/day

Drug: Sodium Bicarbonate (NaHCO3)

Placebo

PLACEBO COMPARATOR

1 tab X2/day

Drug: Placebo

Interventions

Sodium Bicarbonate (NaHCO3)DRUG

Prescribing Sodium Bicaronate for intra-dualytic hypertension

Sodium bicarbonate
PlaceboDRUG

1 tab X 2/day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hemodialysis patient \> 3 months
  • dialysis per week, KTV\>1.2
  • capable of informed concent.
  • Normal volume status, by clinical physician assessment + bioimpedance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir medical center

Ẕerifin, Is, 70300, Israel

Location

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Central Study Contacts

Shani Zilberman Itskovich, Dr.

CONTACT

+97289779383shani.zilberman@mail.huji.ac.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 17, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

blood pressure results, blood tests

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

IL(1)