Status:

TERMINATED

Dialysate Sodium Individualization in Hemodialysis

Lead Sponsor:

Yale University

Collaborating Sponsors:

Satellite Research

Conditions:

Hypertension

Hemodialysis Patients

Eligibility:

All Genders

18-90 years

Phase:

PHASE1

Brief 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...

Detailed Description

Recent evidence from our group shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain,...

Eligibility Criteria

Inclusion

  • ESKD on hemodialysis
  • Hypertension, defined as average pre-HD BP \>150/85 mmHg or use of antihypertensive drugs
  • Average pre-HD serum sodium \<139 mmol/L

Exclusion

  • Intradialytic hypotension
  • Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)
  • Uncontrolled hypertension (average pre-HD BP \>200/105 mmHg)
  • Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)
  • Debilitating illness
  • Inability to provide written informed consent

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT00259714

Start Date

March 1 2006

End Date

April 1 2008

Last Update

July 22 2016

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Davita New Haven Dialysis Unit

New Haven, Connecticut, United States, 06520