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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02639624
Other study ID # 14-01343
Secondary ID
Status Withdrawn
Phase N/A
First received December 22, 2015
Last updated July 27, 2017
Start date January 2016
Est. completion date July 1, 2017

Study information

Verified date July 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.


Description:

Investigators will try to perform dialysis with a low bicarbonate bath which will leave patients blood pH (Hydrogen ion concentration) relatively unchanged then switch to a normal bicarbonate bath during the second half of dialysis so that they attain the pH (Hydrogen ion concentration) they normally would. Investigators will use these measurements to test test the hypothesis that Indoxyl Sulfate (IS) binds to proteins with greater affinity under basic conditions and further to test the hypothesis that it is possible to remove a greater amount of Indoxyl Sulfate (IS) when patients are maintained relatively acidotic during dialysis for a longer period of time due to the greater availability of free IS that can pass through the dialyzer.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Chronic Stable Dialysis for at least 6 months

Exclusion Criteria:

- Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L

- Hospitalization within the past 12 months

- Adults unable to consent

- Children

- Pregnant women

- Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low bicarbonate dialysate First

Normal bicarbonate dialysate First

Normal bicarbonate dialysate

Low bicarbonate dialysate


Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
Secondary Change in pH 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
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