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NCT Number: NCT07231900

Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

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.

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Key information

Conditions

Hypertension in Dialysis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shamir medical center

Ẕerifin, Is, 70300, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Bicarbonate (NaHCO3)

Drug

Prescribing Sodium Bicaronate for intra-dualytic hypertension

Placebo

Drug

1 tab X 2/day

Primary outcomes

  1. Blood pressure

    Time frame: 1 month

    Prevention of intra dialytic hypertension

Study contacts

Contact information is provided by the study sponsor or research team.

Shani Zilberman Itskovich, Dr.

CONTACT

[email protected]

+97289779383

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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