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Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low dialysate flow, smaller dialyzer
high dialysate flow, larger dialyzer
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for End Stage Renal Failure on Dialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto

Exclusion Criteria:

  • recent use of antibiotics
  • gastrointestinal disease

Sites / Locations

  • Satellite Redwood CityRecruiting
  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high dialysate flow, larger dialyzer

low dialysate flow, smaller dialyzer

Arm Description

high dialysate flow, larger dialyzer

low dialysate flow, smaller dialyzer

Outcomes

Primary Outcome Measures

Plasma levels of the chemical p-cresol sulfate

Secondary Outcome Measures

Full Information

First Posted
June 27, 2013
Last Updated
July 9, 2015
Sponsor
Palo Alto Veterans Institute for Research
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1. Study Identification

Unique Protocol Identification Number
NCT01892839
Brief Title
Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
Official Title
Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Veterans Institute for Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hemodialysis keeps patients with renal failure alive but does not restore normal health. Retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. This proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. The effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high dialysate flow, larger dialyzer
Arm Type
Experimental
Arm Description
high dialysate flow, larger dialyzer
Arm Title
low dialysate flow, smaller dialyzer
Arm Type
Active Comparator
Arm Description
low dialysate flow, smaller dialyzer
Intervention Type
Other
Intervention Name(s)
low dialysate flow, smaller dialyzer
Intervention Description
The subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer.
Intervention Type
Other
Intervention Name(s)
high dialysate flow, larger dialyzer
Intervention Description
The subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer.
Primary Outcome Measure Information:
Title
Plasma levels of the chemical p-cresol sulfate
Time Frame
Participants will be followed for 2-3 weeks on different dialysis prescriptions and plasma chemical levels will be measured at the end of this period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto Exclusion Criteria: recent use of antibiotics gastrointestinal disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tim meyer, md
Phone
650-852-3314
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W Meyer, MD
Organizational Affiliation
PAIRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Redwood City
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Meyer, MD
Phone
650-852-3314
Email
twmeyer@stanford.edu
First Name & Middle Initial & Last Name & Degree
Orlando Camacho, MD
Phone
650-852-3314
Email
orlandoc@stanford.edu
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Meyer, MD
Phone
650-852-3314
Email
twmeyer@stanford.edu
First Name & Middle Initial & Last Name & Degree
Orlando Camacho, MD
Phone
650-852-3314
Email
orlandoc@stanford.edu
First Name & Middle Initial & Last Name & Degree
timothy w meyer, md

12. IPD Sharing Statement

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Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis

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