NCT04020757

H+ Mobilization With Dialysate Bicarbonate Variation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-12
• Primary completion: 2019-10-30
• Completion: 2019-11-30
• First posted: 2019-07-16
• Last updated: 2020-03-12

Locations

1 site across 1 country: United States