The Effects of Lowering Dialysate Sodium in Hypertensive... | NCT01455974

Studies
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

NCT01455974

Sponsor

Capital Medical University

Status

Completed

Last Update Posted

Oct 20, 2011Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Hypertension
Arteriosclerosis
Left Ventricular Hypertrophy

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2011

Last Update Posted Date

Oct 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi-Lun Zhou, Associate professor, Capital Medical UniversityPrincipal Investigator

Lead Sponsor

Capital Medical UniversityOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dialysate sodium set at 136 mmol/L	Experimental		Other: Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Baseline, 4 months, and 12 months

Secondary Outcomes

Measure	Description	Time Frame
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	Baseline, 4 months, and 12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology, Chao-Yang Hospital, Capital Medical University		Beijing		100020	China

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D001161	Arteriosclerosis
D017379	Hypertrophy, Left Ventricular

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001157	Arterial Occlusive Diseases
D006332	Cardiomegaly

Browse Leaves

Not provided

Browse Branches

Not provided