Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with 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.

Condition	Intervention	Phase
Hypertension in Hemodialysis Patients	Drug: dialysate sodium individualization	Phase II

Further study details as provided by Yale University:

Primary Outcomes: BP changes on 44-h ABPM; Changes in cardiac output and systemic vascular resistance; Changes in extracellular and extracellular volume
Secondary Outcomes: Changes in measured biochemical markers; Changes in augmentation index; Change in circadian BP profile on 44-h ABPM
Expected Total Enrollment:  17

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, less HD-related symptoms, and better blood pressure control in hypertensive subjects. In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics, body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients. We will use a single-blind cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient’s average serum sodium, subjects will be randomized to 3 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 3 weeks after a 1-week washout period (dialysate Na 140 mmol/L). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drus will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), bioimpedance measurements of intracellular and extracellular volume, and thirst scores will be measured weekly at the mid-week dialysis session. In addition, we will perform interdialytic ambulatory BP monitoring, measurement of arterial stiffness (augmentation index), and measurement of plasma BNP, renin, aldosterone and norepinephrine at baseline and at the end of each block.

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00259714

Aldo J Peixoto, MD      203 9325711  Ext. 2215    aldo.peixoto@yale.edu

Connecticut
      Hartford Hospital, Hartford,  Connecticut,  06102,  United States

Study chairs or principal investigators

Aldo J Peixoto, MD,  Principal Investigator,  Yale University and VA Connecticut Healthcare System   
Jarrod Post, MD,  Principal Investigator,  Hartford Hospital   

Study ID Numbers:  0509000646; 1034978.1.R06791..721688.02
Last Updated:  December 8, 2005
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00259714
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10