H+ Mobilization With Dialysate Bicarbonate Variation

Phase 2

Terminated

• Conditions: Chronic Kidney Disease
• Interventions: Device: variation in dialysis bicarbonate; Dietary Supplement: Zone Perfect bar

• Registration Number: NCT04020757
• Lead Sponsor: Tufts Medical Center

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 \[HCO3-\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-04
• Study Start: 2019-06-12
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Bicarb Variation	Zone Perfect bar	Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3
Bicarb Variation	variation in dialysis bicarbonate	Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States