Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters

Hypertension Clinical Trial

Official title:

The Effect of Low Sodium Dialysate on Ambulatory Blood Pressure Measurement Parameters in Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02621450
• Other study ID #: 2012-51
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 21, 2015
• Last updated: December 8, 2015
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2015
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

End stage renal disease (ESRD) is related with increased cardiovascular mortality and morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis treatment.

Methods: The study will be included 46 patients who had creatinine clearance levels less than 10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium dialysate for six months via computer-generated randomization.

Description:

Patient Selection The present study is a single-center, randomized controlled and double blinded trial. The patients going to enroll for this study had creatinine clearance less than 10 ml/min/1.73 m2 and had been on intermittent HD treatment for at least one year.

The exclusion criteria for the present study are masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency.

Sixty-four patients going to enroll for eligibility and after the initial assessment. Clinic and laboratory profiles of the patients including cause of renal disease, history of HT and antihypertensive treatments going to record by systematic review of the patient files. After the enrollment stage, the patients going to allocate low-sodium dialysate or standard sodium dialysate for 6 months via computer-generated randomization.

They going to dialyze three times a week with synthetic polysulfone (Hollow-fiber, Low Flux, KUF<20, 1.6 m2) membrane, each session lasting 4 hours with bicarbonate dialysate (with 33mmol/L concentration) and 300-350 ml/min blood-flow. .

Study protocol All patients going to assess before and 6 months after the study. Before initiating the study, all patients were dialyzed with 140 mEq/L sodium concentration. In the low-sodium dialysate group, the dialysate sodium concentration going to reduce from 140 to 137mEq/L. To eliminate the acute effects of hemodialysis on the parameters measured, baseline and end-of-study measurements going to perform in non-dialysis day, 24 hours after the mid-week session.

Ambulatory blood pressure measurement Ambulatory BP measurement during 24-hour going to perform using a Space Labs 90207 oscillometric method (Redmond, Washington, USA). The BP measurements going to perform automatically from non-fistula arm. The confirmation of the device going to check with the standard auscultator method in order to ensure that the changes in BP values between the two methods did not exceed +5 mm Hg.

The device going to set to achieve BP evaluation at 30-minute intervals during the night (11:00 PM to 07:00 AM) and at 20-minute intervals during the day (07:00 AM to 11:00 PM).

''Nocturnal dipping'' going to define as a decrease of greater than 10% (when compared with the daytime values) in the systolic or diastolic blood pressure at night. ''Non-nocturnal dipping'' going to define as a decrease of less than 10% (when compared with the daytime values) in the blood pressure parameters levels at night or did not decrease in the systolic or diastolic blood pressure at night

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

The patients with creatinine clearance less than 10 ml/min/1.73 m2 and under intermittent HD treatment for at least one year are included into the study.

Exclusion Criteria as follows:

Masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency -

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hypertension
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• standart dialysis
dialysate sodium consentration 140 mEq
• low sodium dialysis
dialysate sodium consentration will be reducer from 140 mEq to 137 mEq

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

References & Publications (1)

Gümrükçüoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Günes Y, Tuncer M. Effects of lowering dialysate sodium on carotid artery atherosclerosis and endothelial dysfunction in maintenance hemodialysis patients. Int Urol Nephrol. 2012 Dec;44(6):1833-9. doi: 10.1007/s11255-011-0117-5. Epub 2012 Jan 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure measurement		six months	Yes