Dialysate Sodium Individualization in Hemodialysis

NCT00259714 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-07-22

No results posted yet for this study

Summary

Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP control in hypertensive patients. In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker of volume status.

Conditions

Interventions

DRUG

dialysate sodium individualization

Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

DRUG

standard dialysate sodium

The prescribed dialysate sodium is 140 mEq/L

Sponsors & Collaborators

  • Satellite Research

    collaborator UNKNOWN
  • Yale University

    lead OTHER

Principal Investigators

  • Aldo J Peixoto, MD · Yale University and VA Connecticut Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

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 NCT00259714 on ClinicalTrials.gov