Dialysate Sodium Individualization in Hemodialysis

Hypertension Clinical Trial

Official title:

Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00259714
• Other study ID #: 0509000646
• Secondary ID: 1034978.1.R06791
• Status: Terminated
• Phase: Phase 1
• First received: November 28, 2005
• Last updated: July 21, 2016
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients
• Hypertension

Intervention

Drug:
• dialysate sodium individualization
Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").
• standard dialysate sodium
The prescribed dialysate sodium is 140 mEq/L

Locations

Country	Name	City	State
United States	Davita New Haven Dialysis Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Satellite Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. Erratum in: Kidney Int. 2004 Nov;66(5):2108. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BP changes on 44-h ABPM		3 weeks	No
Primary	Changes in cardiac output and systemic vascular resistance		3 weeks	No
Primary	Changes in intracellular and extracellular volume		3 weeks	No
Secondary	Changes in measured biochemical markers		3 weeks	No
Secondary	Changes in augmentation index		3 weeks	No
Secondary	Change in circadian BP profile on 44-h ABPM		3 weeks	No