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The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi-Lun Zhou, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01455974
First received: September 28, 2011
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Hypertension
Arteriosclerosis
Left Ventricular Hypertrophy
 Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Changes in 44-hour ambulatory systolic and diastolic blood pressure [ Time Frame: Baseline, 4 months, and 12 months ] [ Designated as safety issue: Yes ]
    The change is calculated as the 4 months minus baseline, and the 12 months minus baseline


Secondary Outcome Measures:
  • Changes in aortic pulse wave velocity and left ventricular mass index [ Time Frame: Baseline, 4 months, and 12 months ] [ Designated as safety issue: Yes ]
    The change is calculated as the 4 months minus baseline, and the 12 months minus baseline


Enrollment: 16
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455974

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

No publications provided

Responsible Party: Yi-Lun Zhou, Associate professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01455974     History of Changes
Other Study ID Numbers: 001
Study First Received: September 28, 2011
Last Updated: October 19, 2011
Health Authority: China: Ethics Committee

Keywords provided by Capital Medical University:
hypertension
arterial stiffness
left ventricular hypertrophy

Additional relevant MeSH terms:
Arteriosclerosis
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases

ClinicalTrials.gov processed this record on May 23, 2013