Dialysate Sodium Individualization in Hemodialysis
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 7/23/2016 |
| Start Date: | March 2006 |
| End Date: | April 2008 |
Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
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.
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.
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 drugs will remain unchanged throughout the study. Clinical information,
pre/intra/post-HD blood pressure and thirst scores will be measured weekly at the mid-week
dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and
systemic vascular resistance), bioimpedance measurements of intracellular and extracellular
volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity),
interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and
norepinephrine at baseline and at the end of each block.
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 drugs will remain unchanged throughout the study. Clinical information,
pre/intra/post-HD blood pressure and thirst scores will be measured weekly at the mid-week
dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and
systemic vascular resistance), bioimpedance measurements of intracellular and extracellular
volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity),
interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and
norepinephrine at baseline and at the end of each block.
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
We found this trial at
1
site
Click here to add this to my saved trials
