H+ Mobilization With Dialysate Bicarbonate Variation

NCT04020757 | Terminated Phase 2

• 1 other identifier: 13296
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 \[HCO3-\].

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Bicarb Variation

OTHER

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

Device: variation in dialysis bicarbonate; Dietary Supplement: Zone Perfect bar

Interventions

variation in dialysis bicarbonate 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

Bicarb Variation

Zone Perfect bar DIETARY_SUPPLEMENT

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

Bicarb Variation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 )

Sponsors & Collaborators

• Tufts Medical Center: lead
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 16, 2019
• Study Start: June 12, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)