The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

Not Applicable

Completed

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

• Registration Number: NCT01455974
• Lead Sponsor: Capital Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-02
• Study Completion: 2011-09
• Study First Submitted: 2011-09-28
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-19
• Last Update Submitted: 2011-10-19
• Study First Posted: 2011-10-20
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialysate sodium set at 136 mmol/L	Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nephrology, Chao-Yang Hospital, Capital Medical University; 🇨🇳 Beijing, China