H+ Mobilization With Dialysate Bicarbonate Variation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2019-11-30

Brief Summary

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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 \[HCO3-\].

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bicarb Variation

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

Group Type OTHER

variation in dialysis bicarbonate

Intervention Type DEVICE

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

Zone Perfect bar

Intervention Type DIETARY_SUPPLEMENT

16g protein supplement given during first 30 mins of dialysis on last testing day

Interventions

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variation 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

Intervention Type DEVICE

Zone Perfect bar

16g protein supplement given during first 30 mins of dialysis on last testing day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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 )

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No