Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNYU Langone Health

About this trial

16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Receiving outpatient maintenance HD therapy.

Age ≥ 21 years.

Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.

Disqualifiers

Currently incarcerated.

Insufficient capacity for informed consent.

Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.

Unscheduled HD for hyperkalemia within ≤30 days.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Standard Table Salt

    Dietary supplement

    Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.

  • Salt Substitute

    Dietary supplement

    Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt. Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Standard Table Salt, then Salt SubstituteExperimental treatment 2 interventions
Group B: Salt Substitute, then Standard Table SaltExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Serum Potassium Concentration During First Treatment Period

Serum potassium concentration expressed in milliequivalents per liter (mEq/L).

Time frame
Day 1, Day 16
2

Change in Serum Potassium Concentration During Second Treatment Period

Serum potassium concentration expressed in mEq/L.

Time frame
Day 36, Day 52

Secondary outcomes

1

Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period

Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The first treatment period spans from Day 1 to Day 16.

Time frame
Up to Day 16
2

Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period

Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The second treatment period spans from Day 36 to Day 52.

Time frame
From Day 36 up to Day 52
3

Number of Participants Presenting with Moderate Hyperkalemia

Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.

Time frame
Up to Day 52
4

Mean Potassium Concentration During First Treatment Period

Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.

Time frame
Up to Day 16

Other outcomes

Sponsors and contacts

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