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出境医 / 临床实验 / H+ Mobilization With Dialysate Bicarbonate Variation

H+ Mobilization With Dialysate Bicarbonate Variation

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 12, 2019
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : November 30, 2019
Arms and Interventions
Arm Intervention/treatment
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 [ Time Frame: through study completion, a period of 3 weeks ]
    7 tests conducted through the dialysis treatment after the long interdialytic interval

  2. H+ mobilization [ Time Frame: through study completion, a period of 3 weeks ]
    7 tests conducted through the dialysis treatment after the long interdialytic interval


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Dialysis Clinic, Inc.
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date March 12, 2020
Actual Study Start Date  ICMJE June 12, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Lactate levels [ Time Frame: through study completion, a period of 3 weeks ]
    7 tests conducted through the dialysis treatment after the long interdialytic interval
  • H+ mobilization [ Time Frame: through study completion, a period of 3 weeks ]
    7 tests conducted through the dialysis treatment after the long interdialytic interval
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE H+ Mobilization With Dialysate Bicarbonate Variation
Official Title  ICMJE H+ Mobilization With Dialysate Bicarbonate Variation
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-].
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE Bicarb Variation
Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3
Interventions:
  • Device: variation in dialysis bicarbonate
  • Dietary Supplement: Zone Perfect bar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2020) 		13
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		20
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 )
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020757
Other Study ID Numbers  ICMJE 13296
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Dialysis Clinic, Inc.
Investigators  ICMJE Not Provided
PRS Account Tufts Medical Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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