- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455974
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100020
- Department of Nephrology, Chao-Yang Hospital, Capital Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dialysate sodium set at 136 mmol/L
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in 44-hour ambulatory systolic and diastolic blood pressure
Time Frame: Baseline, 4 months, and 12 months
|
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
|
Baseline, 4 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in aortic pulse wave velocity and left ventricular mass index
Time Frame: Baseline, 4 months, and 12 months
|
The change is calculated as the 4 months minus baseline, and the 12 months minus baseline
|
Baseline, 4 months, and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arteriosclerosis
-
Daewoong Pharmaceutical Co. LTD.CompletedArteriosclerosis ObliteransKorea, Republic of
-
Jun-min BaoUnknownArteriosclerosis; ExtremitiesChina
-
Kansai Rosai HospitalAssociation for Establishment of Ebvidence in InterventionsUnknownArteriosclerosis ObliteransJapan
-
Region Örebro CountyRecruitingCoronary Stenosis | Calcific Coronary ArteriosclerosisSweden
-
GE HealthcareTurku University Hospital; University of Turku; The Finnish Funding Agency for...CompletedArteriosclerosis ObliteransFinland
-
Guangzhou Yipinhong Pharmaceutical CO.,LTDUnknownArteriosclerosis ObliteransChina
-
Medtronic CardiovascularCompletedArteriosclerosis of Coronary Artery Bypass GraftCanada, United States
-
Johns Hopkins UniversityNorthwestern UniversityCompletedCoronary Artery Disease | Coronary Arteriosclerosis | Coronary Atherosclerosis | Atherosclerosis, Coronary | Arteriosclerosis, CoronaryUnited States
-
Cordis CorporationCompletedCoronary Arteriosclerosis | Angioplasty, Transluminal, Percutaneous Coronary | Peripheral ArteriosclerosisUnited States
-
University of VermontNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Atherosclerosis | Coronary Arteriosclerosis | Cerebrovascular Accident | Cerebral Arteriosclerosis
Clinical Trials on Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
-
Brigham and Women's HospitalCompletedIntra-dialytic HypotensionUnited States
-
University Hospital, MontpellierRecruitingAcute Kidney Injury | Renal Replacement TherapyFrance
-
Yale UniversityTerminatedSafety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic HypotensionHemodialysis | HypotensionUnited States
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR); ICESActive, not recruitingKidney Diseases | Hemodialysis | End-Stage Kidney DiseaseCanada
-
Iain BressendorffCompletedEndstage Renal DiseaseDenmark
-
VA Office of Research and DevelopmentRecruitingEnd-stage Renal DiseaseUnited States
-
Dokuz Eylul UniversityCukurova University; Kanuni Sultan Suleyman Training and Research Hospital; Baskent... and other collaboratorsCompletedFluid Therapy | Newborn Complication | Isotonic Dehydration | Hyponatremia of Newborn | Hypernatremia of Newborn | Sodium ChlorideTurkey
-
Ulrik GrevstadCompletedKnee Replacement ArthroplastyDenmark
-
Rigshospitalet, DenmarkTrygFonden, DenmarkCompletedAnemia | Arthroplasty | Hip | ReplacementDenmark
-
Rigshospitalet, DenmarkTrygFonden, DenmarkCompleted