Status:
TERMINATED
H+ Mobilization With Dialysate Bicarbonate Variation
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Dialysis Clinic, Inc.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 )
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04020757
Start Date
June 12 2019
End Date
November 30 2019
Last Update
March 12 2020
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111