Dialysate Sodium Individualization in Hemodialysis

NCT ID: NCT00259714

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

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 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.

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, 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.

Conditions

Hypertension; Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard dialysate sodium

In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L

Group Type: ACTIVE_COMPARATOR

standard dialysate sodium

Intervention Type: DRUG

The prescribed dialysate sodium is 140 mEq/L

dialysate sodium individualization

.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

Group Type: EXPERIMENTAL

dialysate sodium individualization

Intervention Type: DRUG

Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

Interventions

dialysate sodium individualization

Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

Intervention Type: DRUG

standard dialysate sodium

The prescribed dialysate sodium is 140 mEq/L

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satellite Research

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo J Peixoto, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University and VA Connecticut Healthcare System

Locations

Davita New Haven Dialysis Unit

New Haven, Connecticut, United States

Countries

United States

References

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. doi: 10.1111/j.1523-1755.2004.00876.x.

Reference Type: BACKGROUND

PMID: 15327422 (View on PubMed)

Other Identifiers

1034978.1.R06791..721688.02

Identifier Type: -

Identifier Source: secondary_id

0509000646

Identifier Type: -

Identifier Source: org_study_id