H+ Mobilization With Dialysate Bicarbonate Variation

Stopped early · Phase 2

Conditions studied: Chronic Kidney Disease

In brief

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 \[HCO3-\].

Key facts

Study ID: NCT04020757
Run by: Tufts Medical Center
People needed: 13
Starts: 2019-06-12
Expected to finish: 2019-11-30
Last updated by the study team: 2020-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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