Sodium Bicarbonate in Intra-dialytic Hypertension in Chro... | NCT07231900

Studies
Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

NCT07231900

Sponsor

Assaf-Harofeh Medical Center

Status

Not yet recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

40Estimated

Phase

Phase 2Phase 3

Conditions

Hypertension in Dialysis Patients

Interventions

Sodium Bicarbonate (NaHCO3)
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2025Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 14, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium bicarbonate	Experimental	PO Sodium bicarbonate 500mg X2/day	Drug: Sodium Bicarbonate (NaHCO3)
Placebo	Placebo Comparator	1 tab X2/day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Bicarbonate (NaHCO3)	Drug	Prescribing Sodium Bicaronate for intra-dualytic hypertension	Sodium bicarbonate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shani Zilberman Itskovich, Dr.	Contact	+97289779383		shani.zilberman@mail.huji.ac.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shamir medical center		Ẕerifin	Is	70300	Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

blood pressure results, blood tests

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017693	Sodium Bicarbonate

Ancestor Terms

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic

Browse Leaves

Not provided

Browse Branches

Not provided