Haemodialysis Salt Reduction Study

NCT00141609 | Completed

• 1 other identifier: LREC 04.0013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure, Chronic; Hypertension

Keywords

End-stage renal failure; Haemodialysis; Sodium; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in pre-dialysis systolic blood pressure

Secondary Outcomes (5)

• 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)

Interventions

Slow Sodium DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant intercurrent illness
• Systolic BP \>240 mmHg/diastolic BP \>120 mmHg at enrollment
• Unstable blood pressure whilst on HD
• Sodium profiled haemodialysis/HDF

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

Blood Pressure Unit, Cardiac & Vascular Sciences, SGUL

London, SW17 0RE, United Kingdom

Location

Related Publications (1)

• McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

  PMID: 34164803 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothy WR Doulton, MBBS BSc MRCP

  SGUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: April 1, 2004
• Study Completion: October 1, 2006
• Last Updated: May 14, 2007

Record last verified: 2007-05

Locations

GB (1)