Not yet recruiting NCT07231900
Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Bicarbonate (NaHCO3), Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension in Dialysis Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Sodium Bicarbonate (NaHCO3)
Prescribing Sodium Bicaronate for intra-dualytic hypertension - Drug Placebo
1 tab X 2/day
Primary outcome measures
- Blood pressure [Time frame: 1 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Shamir medical center — Ẕerifin
Identifiers
NCT: NCT07231900 · 0208-25-ASF