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Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters

Primary Purpose

Chronic Renal Failure, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standart dialysis
low sodium dialysis
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Renal Failure focused on measuring chronic renal failure, hypertension, ampulatory blood pressure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Other

    Arm Label

    standart dialysate

    low sodium dialysate

    Arm Description

    dialysate sodium 140 mEq/L

    dialysate sodium will be reduced from 140 mEq/L to 137 mEq/L

    Outcomes

    Primary Outcome Measures

    Ambulatory blood pressure measurement

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2015
    Last Updated
    December 8, 2015
    Sponsor
    Yuzuncu Yıl University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02621450
    Brief Title
    Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters
    Official Title
    The Effect of Low Sodium Dialysate on Ambulatory Blood Pressure Measurement Parameters in Patients Undergoing Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yuzuncu Yıl University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Renal Failure, Hypertension
    Keywords
    chronic renal failure, hypertension, ampulatory blood pressure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standart dialysate
    Arm Type
    Placebo Comparator
    Arm Description
    dialysate sodium 140 mEq/L
    Arm Title
    low sodium dialysate
    Arm Type
    Other
    Arm Description
    dialysate sodium will be reduced from 140 mEq/L to 137 mEq/L
    Intervention Type
    Biological
    Intervention Name(s)
    standart dialysis
    Intervention Description
    dialysate sodium consentration 140 mEq
    Intervention Type
    Biological
    Intervention Name(s)
    low sodium dialysis
    Intervention Description
    dialysate sodium consentration will be reducer from 140 mEq to 137 mEq
    Primary Outcome Measure Information:
    Title
    Ambulatory blood pressure measurement
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hasan ali gümrükçüoğlu
    Organizational Affiliation
    Yuzuncu Yil Univesty
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22246593
    Citation
    Gumrukcuoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Gunes 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.
    Results Reference
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