Back to resultsH+ Mobilization With Dialysate Bicarbonate Variation
Primary Purpose
Chronic Kidney Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
variation in dialysis bicarbonate
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About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 )
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bicarb Variation
Arm Description
Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3
Outcomes
Primary Outcome Measures
Lactate levels
7 tests conducted through the dialysis treatment after the long interdialytic interval
H+ mobilization
7 tests conducted through the dialysis treatment after the long interdialytic interval
Secondary Outcome Measures
Full Information
NCT ID
NCT04020757
First Posted
June 4, 2019
Last Updated
March 10, 2020
Sponsor
Tufts Medical Center
Collaborators
Dialysis Clinic, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04020757
Brief Title
H+ Mobilization With Dialysate Bicarbonate Variation
Official Title
H+ Mobilization With Dialysate Bicarbonate Variation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Biochemical measurement techniques were deemed insufficient to continue research
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Dialysis Clinic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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-].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicarb Variation
Arm Type
Other
Arm Description
Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3
Intervention Type
Device
Intervention Name(s)
variation in dialysis bicarbonate
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
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Intervention Description
16g protein supplement given during first 30 mins of dialysis on last testing day
Primary Outcome Measure Information:
Title
Lactate levels
Description
7 tests conducted through the dialysis treatment after the long interdialytic interval
Time Frame
through study completion, a period of 3 weeks
Title
H+ mobilization
Description
7 tests conducted through the dialysis treatment after the long interdialytic interval
Time Frame
through study completion, a period of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 )
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
H+ Mobilization With Dialysate Bicarbonate Variation
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