The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient in hemodialysis treatment results in absolute sodium removal via diffusive transport of sodium from the blood to the dialysate, and it may be a potentially useful tool to improve sodium loading due to excess dietary sodium intake.

The purpose of this study is to determine whether a in small negative sodium gradient could improve blood pressure level, arterial stiffness and left ventricular hypertrophy in hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight assessed by bioimpedance spectroscopy.

Study Overview

• Status: Completed
• Conditions: Arteriosclerosis; Hypertension; Left Ventricular Hypertrophy
• Intervention / Treatment: Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L

Detailed Description

A number of studies have shown that lowering dialysate sodium concentration could improve blood pressure (BP) control, and the lower BPs are considered to be a result of an improvement in volume status via increasing sodium removal. However, sodium, apart from volume, may have an independent effect on BP regulation. It is speculated that a reduction in exchangeable sodium, even without a change in body water content, may improve BP control. Unfortunately, as of yet, no clinical studies have actually provided the evidence in this field.

In general population, dietary salt loading produces significant increase in aortic pulse wave velocity, which is reversed by lowering sodium intake. To the investigators knowledge, the effect of sodium on arterial stiffness has not been investigated in hemodialysis patients.

A regression of left ventricular hypertrophy (LVH) has been achieved through strict dietary sodium restriction in hemodialysis patients. Lack of effect on LVH was observed in low sodium dialysis which may be due to the shorter time interval.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Department of Nephrology, Chao-Yang Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• They had been on HD for more than 1 year.
• They had had no clinical cardiovascular disease during 3 months preceding entry into the study, with left ventricular ejection fraction over 40%.
• Their residual daily urine output was lower than 100 ml/day.
• They had achieved their dry weight assessed by bioimpedance technique and clinical examination for at least 3 months.
• A mean interdialytic ambulatory BP of >135/85 mmHg.
• Averaging the last six available monthly pre-dialysis plasma sodium concentrations over the preceding 12 months >138mmol/l.

Exclusion Criteria:

• They had known acute inflammatory event, malignant disease, and the serum albumine<30g/l.
• They were diabetic and hypotension prone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialysate sodium set at 136 mmol/L	Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L; After 1-month period of dialysis with standard dialysate sodium concentration 138mmol/L, patients were followed up over a 1-year period with dialysate sodium set at 136mmol/L, without changes in instructions to patients about dietary sodium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in 44-hour ambulatory systolic and diastolic blood pressure	The change is calculated as the 4 months minus baseline, and the 12 months minus baseline	Baseline, 4 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in aortic pulse wave velocity and left ventricular mass index	The change is calculated as the 4 months minus baseline, and the 12 months minus baseline	Baseline, 4 months, and 12 months

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 20, 2011
• Last Update Submitted That Met QC Criteria: October 19, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: hypertension; arterial stiffness; left ventricular hypertrophy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Cardiomegaly; Hypertension; Hypertrophy; Arteriosclerosis; Hypertrophy, Left Ventricular; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)