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

NCT ID: NCT01892839

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

high dialysate flow, larger dialyzer

high dialysate flow, larger dialyzer

Group Type: EXPERIMENTAL

high dialysate flow, larger dialyzer

Intervention Type: OTHER

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.

low dialysate flow, smaller dialyzer

low dialysate flow, smaller dialyzer

Group Type: ACTIVE_COMPARATOR

low dialysate flow, smaller dialyzer

Intervention Type: OTHER

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.

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy W Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

PAIRE

Locations

Satellite Redwood City

Redwood City, California, United States

Site Status: RECRUITING

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

tim meyer, md

Role: CONTACT

650-852-3314

Facility Contacts

Tim Meyer, MD

Role: primary

twmeyer@stanford.edu

650-852-3314

Orlando Camacho, MD

Role: backup

orlandoc@stanford.edu

650-852-3314

Timothy Meyer, MD

Role: primary

twmeyer@stanford.edu

650-852-3314

Orlando Camacho, MD

Role: backup

orlandoc@stanford.edu

650-852-3314

Other Identifiers

MEY0026APR

Identifier Type: -

Identifier Source: org_study_id