H+ Mobilization With Dialysate Bicarbonate Variation

Tufts University

Status and phase: Terminated; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Zone Perfect bar; Device: variation in dialysis bicarbonate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04020757

13296

Details and patient eligibility

About

The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath [HCO3-] of 35 mEq/L and an [acetate] of 4 mEq/L, and second, to determine whether reducing bath [HCO3-] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood [HCO3-]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath [HCO3-].

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be 18 years or older,
2. Have been on dialysis for at least 1 year,
3. Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
4. Be reasonably nourished (serum albumin > 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
5. Self-reported urine output of <200 cc/day
6. Functioning arteriovenous fistulas or grafts for dialysis access
7. Currently dialyzing at a dialysate [HCO3-] of 33-37 mEq/L.

Exclusion criteria

1. Pregnancy,
2. Acute illnesses of any kind,
3. Hospitalization in the prior 3 months (except for vascular access related),
4. Significant congestive heart failure, liver or lung failure.
5. Pre-dialysis blood [HCO3-] <19 mEq/L) (to reduce the risk of metabolic acidosis )

Trial design

13 participants in 1 patient group

Bicarb Variation

Other group

Description:

Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3

Treatment:

Device: variation in dialysis bicarbonate

Dietary Supplement: Zone Perfect bar