Recruiting

Hemodialysis

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT01892839

Conditions

End Stage Renal Failure on Dialysis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

low dialysate flow, smaller dialyzer

high dialysate flow, larger dialyzer

Study Details

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.

Conditions

End Stage Renal Failure on Dialysis

Study ID

NCT01892839

Start date

Jul, 2013

Status verified date

Jul, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: high dialysate flow, larger dialyzer

high dialysate flow, larger dialyzer

active comparator: low dialysate flow, smaller dialyzer

low dialysate flow, smaller dialyzer

Interventions

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

tim meyer, md

650-852-3314

Locations

Satellite Redwood City

Recruiting

Redwood City, California, United States, 94063

Contacts

Tim Meyer, MD

650-852-3314twmeyer@stanford.edu

Orlando Camacho, MD

650-852-3314orlandoc@stanford.edu

Stanford University

Recruiting

Stanford, California, United States, 94301

Contacts

Timothy Meyer, MD

650-852-3314twmeyer@stanford.edu

Orlando Camacho, MD

650-852-3314orlandoc@stanford.edu

Principal Investigator:

timothy w meyer, md

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Jul 13, 2015

Last verified

Jul, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2015-07-13.