The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455974
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : October 20, 2011
Information provided by (Responsible Party):
Yi-Lun Zhou, 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.

Condition or disease Intervention/treatment Phase
Hypertension Arteriosclerosis Left Ventricular Hypertrophy Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : September 2011

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.

Primary Outcome Measures :
  1. Changes in 44-hour ambulatory systolic and diastolic blood pressure [ Time Frame: 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 :
  1. Changes in aortic pulse wave velocity and left ventricular mass index [ Time Frame: Baseline, 4 months, and 12 months ]
    The change is calculated as the 4 months minus baseline, and the 12 months minus baseline

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455974

Department of Nephrology, Chao-Yang Hospital, Capital Medical University
Beijing, China, 100020
Sponsors and Collaborators
Capital Medical University

Responsible Party: Yi-Lun Zhou, Associate professor, Capital Medical University Identifier: NCT01455974     History of Changes
Other Study ID Numbers: 001
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Yi-Lun Zhou, Capital Medical University:
arterial stiffness
left ventricular hypertrophy

Additional relevant MeSH terms:
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Heart Diseases
Dialysis Solutions
Pharmaceutical Solutions