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Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

NCT02639624 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-07-31

No results posted yet for this study

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.

Conditions

  • Renal Dialysis
  • Hemodialysis

Interventions

DRUG

Low bicarbonate dialysate First

DRUG

Normal bicarbonate dialysate First

DRUG

Normal bicarbonate dialysate

DRUG

Low bicarbonate dialysate

Sponsors & Collaborators

Principal Investigators

  • Jerome Lowenstein · New York University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-01
Completion
2017-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639624 on ClinicalTrials.gov