MedTrace Logo

Acid-Base Composition With Use of hemoDialysates

NCT02334267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-03-09

Study results available
· View outcomes & findings →

Summary

This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid dialysate concentrates in prevalent hemodialysis patients.

Conditions

Interventions

DEVICE

Group 1: GranuFlo

Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

DEVICE

Group 2: NaturaLyte

Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Sponsors & Collaborators

  • Fresenius Medical Care North America

    lead INDUSTRY

Principal Investigators

  • William B Smith, MD · Volunteer Research Group and New Orleans Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-02-28
Completion
2015-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02334267 on ClinicalTrials.gov