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

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ClinicalTrials.gov Identifier: NCT01892839
Recruitment Status : Unknown
Verified July 2015 by Palo Alto Veterans Institute for Research.
Recruitment status was:  Recruiting
First Posted : July 4, 2013
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Palo Alto Veterans Institute for Research

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Other: low dialysate flow, smaller dialyzer Other: high dialysate flow, larger dialyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
Study Start Date : July 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: high dialysate flow, larger dialyzer
high dialysate flow, larger dialyzer
Other: high dialysate flow, larger dialyzer
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.

Active Comparator: low dialysate flow, smaller dialyzer
low dialysate flow, smaller dialyzer
Other: low dialysate flow, smaller dialyzer
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.




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892839


Contacts
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Contact: tim meyer, md 650-852-3314

Locations
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United States, California
Satellite Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Tim Meyer, MD    650-852-3314    twmeyer@stanford.edu   
Contact: Orlando Camacho, MD    650-852-3314    orlandoc@stanford.edu   
Stanford University Recruiting
Stanford, California, United States, 94301
Contact: Timothy Meyer, MD    650-852-3314    twmeyer@stanford.edu   
Contact: Orlando Camacho, MD    650-852-3314    orlandoc@stanford.edu   
Principal Investigator: timothy w meyer, md         
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Investigators
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Principal Investigator: Timothy W Meyer, MD PAIRE

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Responsible Party: Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT01892839     History of Changes
Other Study ID Numbers: MEY0026APR
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dialysis Solutions
Pharmaceutical Solutions