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Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

NCT00237783 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-07-26

No results posted yet for this study

Summary

Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.

Conditions

Interventions

DRUG

dialysate sodium (140 mmol/L)

DRUG

individualized dialysate sodium

individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

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 NCT00237783 on ClinicalTrials.gov