The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
Primary Purpose
Hypertension, Arteriosclerosis, Left Ventricular Hypertrophy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, arterial stiffness, left ventricular hypertrophy
Eligibility 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.
Sites / Locations
- Department of Nephrology, Chao-Yang Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dialysate sodium set at 136 mmol/L
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01455974
First Posted
September 28, 2011
Last Updated
October 19, 2011
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01455974
Brief Title
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Arteriosclerosis, Left Ventricular Hypertrophy
Keywords
hypertension, arterial stiffness, left ventricular hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialysate sodium set at 136 mmol/L
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
Intervention Description
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 Measure Information:
Title
Changes in 44-hour ambulatory systolic and diastolic blood pressure
Description
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
Time Frame
Baseline, 4 months, and 12 months
Secondary Outcome Measure Information:
Title
Changes in aortic pulse wave velocity and left ventricular mass index
Description
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
Time Frame
Baseline, 4 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Nephrology, Chao-Yang Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
We'll reach out to this number within 24 hrs