H+ Mobilization With Dialysate Bicarbonate Variation

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04020757
• Collaborator: Dialysis Clinic, Inc. (Industry)
• Enrollment: 13
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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-].

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Device: variation in dialysis bicarbonate; Dietary Supplement: Zone Perfect bar	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: H+ Mobilization With Dialysate Bicarbonate Variation
• Actual Study Start Date: Jun 12, 2019
• Actual Primary Completion Date: Oct 30, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lactate levels [through study completion, a period of 3 weeks]

   7 tests conducted through the dialysis treatment after the long interdialytic interval

2. H+ mobilization [through study completion, a period of 3 weeks]

   7 tests conducted through the dialysis treatment after the long interdialytic interval

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 )

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center
• Dialysis Clinic, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT04020757
• Other Study ID Numbers: 13296
• First Posted: Jul 16, 2019
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 12, 2020