Chronic Kidney Disease
Conditions
Brief summary
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 \[HCO3-\].
Interventions
DEVICEvariation in dialysis bicarbonate
35 mEq/L dialysate bicarbonate for one week, followed by 30 mEq/L for one week, followed by 35mEq/L for one week with nutritional supplement during dialysis
DIETARY_SUPPLEMENTZone Perfect bar
16g protein supplement given during first 30 mins of dialysis on last testing day
Sponsors
Dialysis Clinic, Inc.
Tufts Medical Center
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactate levels | through study completion, a period of 3 weeks | 7 tests conducted through the dialysis treatment after the long interdialytic interval |
| H+ mobilization | through study completion, a period of 3 weeks | 7 tests conducted through the dialysis treatment after the long interdialytic interval |
Countries
United States
Outcome results
None listed