Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Hypertension in Dialysis Patients

Treatments: Drug: Placebo; Drug: Sodium Bicarbonate (NaHCO3)

Study type: Interventional

Funder types: Other

Identifiers

NCT07231900

0208-25-ASF

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Sodium bicarbonate

Experimental group

Description:

PO Sodium bicarbonate 500mg X2/day

Treatment:

Drug: Sodium Bicarbonate (NaHCO3)

Placebo

Placebo Comparator group

Description:

1 tab X2/day

Treatment:

Drug: Placebo