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Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07231900
Enrollment
40
Registered
2025-11-17
Start date
2025-11-10
Completion date
2027-12-01
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension in Dialysis Patients

Keywords

Intra-dialytic hypertension

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.

Interventions

Prescribing Sodium Bicaronate for intra-dualytic hypertension

DRUGPlacebo

1 tab X 2/day

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure1 monthPrevention of intra dialytic hypertension

Countries

Israel

Contacts

Primary ContactShani Zilberman Itskovich, Dr.
shani.zilberman@mail.huji.ac.il+97289779383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026