Dialysate Sodium Individualization in Hemodialysis
Stopped early · Phase 1
Conditions studied: Hypertension, Hemodialysis Patients
In brief
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.
Key facts
- Study ID
- NCT00259714
- Run by
- Yale University
- People needed
- 1
- Starts
- 2006-03-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2016-07-22
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Davita New Haven Dialysis Unit — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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