The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients

NCT01455974 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Arteriosclerosis; Left Ventricular Hypertrophy

Keywords

hypertension; arterial stiffness; left ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Changes in aortic pulse wave velocity and left ventricular mass index

  Baseline, 4 months, and 12 months

Study Arms (1)

Dialysate sodium set at 136 mmol/L

EXPERIMENTAL

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

Interventions

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.

Dialysate sodium set at 136 mmol/L

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• They had known acute inflammatory event, malignant disease, and the serum albumine\<30g/l.
• They were diabetic and hypotension prone.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

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

Beijing, 100020, China

Location

MeSH Terms

Conditions

Hypertension; Arteriosclerosis; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

CN (1)