Haemodialysis Salt Reduction Study

This study has been completed.
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00141609
First received: August 31, 2005
Last updated: May 10, 2007
Last verified: May 2007
  Purpose

High blood pressure (hypertension) affects up to 80% of all patients receiving haemodialysis for chronic kidney disease (CKD). High blood pressure is a major cause cardiovascular disease (i.e. strokes, heart attacks and heart failure) and, thereby, cardiovascular deaths in these patients.

A significant cause of raised blood pressure in haemodialysis patients is thought to be due to retention of salt in the body. In healthy people the kidneys excrete salt but the kidneys of patients with CKD cannot do this, so salt has to be removed by dialysis. However dialysis cannot remove as much salt as is necessary, and so it accumulates. This fact has been recognized for many years, and health professionals caring for haemodialysis patients often stress the importance of restriction of dietary salt intake.

However no research has looked in detail at the mechanisms by which salt raises blood pressure in haemodialysis patients. It is likely that salt directly affects thirst, causing patients to drink more and become overloaded with fluid. In addition, salt may have direct effects on the blood vessel wall, causing failure of adequate blood vessel relaxation. Both of these factors may raise blood pressure.

We will conduct a carefully controlled crossover study looking at the effects of a modest reduction in salt intake on BP. During the course of the study, which will last eight weeks, patients will receive both a 5 gram per day and a 10 gram per day salt intake. We will look at how thirst, fluid intake, a number of markers of blood vessel function and blood pressure differ on these two salt intakes.


Condition Intervention
Kidney Failure, Chronic
Hypertension
Drug: Slow Sodium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study Looking at the Effects of a Modest Reduction in Dietary Salt Intake on Blood Pressure Control in Haemodialysis Patients

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Change in pre-dialysis systolic blood pressure

Secondary Outcome Measures:
  • Change in post-dialysis ambulatory BP (24 hr)
  • Change in thirst score
  • Change in intra-dialytic weight gain
  • Change in systemic vascular resistance
  • Change in assymmetric dimethylarginine (ADMA)

Estimated Enrollment: 20
Study Start Date: April 2004
Estimated Study Completion Date: October 2006
Detailed Description:

High blood pressure (BP) is a major independent risk factor for cardiovascular mortality in individuals on haemodialysis, and yet BP is extremely poorly controlled in this population.

Excessive dietary salt intake is likely to be a major cause of hypertension in these patients. Firstly, excessive salt intake will result in thirst, excessive fluid intake and weight gains between dialysis, and thereby chronic over-expansion of extracellular fluid volumes resulting in high blood pressure. Secondly, salt may have direct effects on the arterial tree contributing to endothelial dysfunction that has clearly been demonstrated in uraemic individuals, including haemodialysis patients. Abnormalities in endothelial nitric oxide (NO) production may play an important role in salt-sensitive hypertension, mediated by the potent inhibitor of NO synthase, asymmetrical dimethylarginine (ADMA). Plasma ADMA concentrations are several-fold higher in individuals on dialysis than in normal controls, and it would be of interest to see whether ADMA concentrations decrease with a reduction dietary salt intake.

In spite of the importance of dietary salt intake in haemodialysis patients, there are no controlled studies which delineate the mechanisms by which salt intake affects BP. We propose to conduct a prospective double-blind placebo controlled cross-over study of normal (10 to 12 grams salt per day) versus modestly reduced (6 grams per day) salt intake over an eight week period in haemodialysis patients. The primary outcome measure is the change in pre-dialysis systolic BP. Other outcome measures include mean systolic and diastolic BP as measured by ABPM, thirst scores, daily weight gains and thoracic fluid content, as measured by thoracic bioimpedance. Furthermore, in a sub-group of subjects will we study the changes in plasma ADMA concentrations with reductions in salt intake, and examine correlations with changes in BP and systemic vascular resistance.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Haemodialysis/haemodiafiltration for ESRF for >3 months
  • Clinically stable

Exclusion Criteria:

  • Significant intercurrent illness
  • Systolic BP >240 mmHg/diastolic BP >120 mmHg at enrollment
  • Unstable blood pressure whilst on HD
  • Sodium profiled haemodialysis/HDF
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141609

Locations
United Kingdom
Blood Pressure Unit, Cardiac & Vascular Sciences, SGUL
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Timothy WR Doulton, MBBS BSc MRCP SGUL
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141609     History of Changes
Other Study ID Numbers: LREC 04.0013
Study First Received: August 31, 2005
Last Updated: May 10, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
End-stage renal failure
Haemodialysis
Sodium
Blood Pressure

Additional relevant MeSH terms:
Hypertension
Kidney Failure, Chronic
Renal Insufficiency
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014