H+ Mobilization With Dialysate Bicarbonate Variation

Chronic Kidney Disease Clinical Trial

Official title:

H+ Mobilization With Dialysate Bicarbonate Variation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04020757
• Other study ID #: 13296
• Status: Terminated
• Phase: Phase 2
• Start date: June 12, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate levels	7 tests conducted through the dialysis treatment after the long interdialytic interval	through study completion, a period of 3 weeks
Primary	H+ mobilization	7 tests conducted through the dialysis treatment after the long interdialytic interval	through study completion, a period of 3 weeks