Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

age under 18,

pregnancy

unable to sign informed concent

planned for kidney transplant in the following 3 month.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sodium Bicarbonate (NaHCO3)

    Drug

    Prescribing Sodium Bicaronate for intra-dualytic hypertension

  • Placebo

    Drug

    1 tab X 2/day

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sodium bicarbonateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure

Prevention of intra dialytic hypertension

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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