H+ Mobilization With Dialysate Bicarbonate Variation

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-].

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Device: variation in dialysis bicarbonate; Dietary supplement: Zone Perfect bar

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bicarb Variation; Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3	Device: 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; Dietary supplement: Zone Perfect bar; 16g protein supplement given during first 30 mins of dialysis on last testing day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate levels	7 tests conducted through the dialysis treatment after the long interdialytic interval	through study completion, a period of 3 weeks
H+ mobilization	7 tests conducted through the dialysis treatment after the long interdialytic interval	through study completion, a period of 3 weeks

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Dialysis Clinic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 13296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No