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The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

NCT ID: NCT01455974

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Hypertension Arteriosclerosis Left Ventricular Hypertrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dialysate sodium set at 136 mmol/L

Group Type EXPERIMENTAL

Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yi-Lun Zhou

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nephrology, Chao-Yang Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id