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Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation

NCT ID: NCT00307463

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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This study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume control (by strict dietary salt restriction and persistent ultrafiltration) without using antihypertensive drugs on cardiac structure and inflammation.

Detailed Description

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This randomised, controlled and prospective study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus persistent strict volume control without using antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation.

We hypothesize that better blood pressure control and regression of left ventricular mass may be reached by a policy of strict volume control consisting of strict dietary salt restriction and persistent ultrafiltration.

258 Hypertensive hemodialysis patients (BP\>130/80 mmHg and/or being on antihypertensive medication) will be randomized to two arms:

Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be applied.

Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

The patients will be evaluated at 12 months for primary outcomes. Primary end-points are significant changes in left ventricular hypertrophy and left ventricular mass and significant change in left ventricular end-diastolic volume.

Secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin, BNP and hsCRP levels.

Conditions

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End-stage Renal Disease

Keywords

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end-stage renal disease hemodialysis volume control ultrafiltration inflammation cardiovascular disease left ventricular hypertrophy dietary salt restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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strict volume control policy

strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.

Group Type ACTIVE_COMPARATOR

strict volume control policy

Intervention Type PROCEDURE

strict volume control by UF and dietary salt restriction

antihypertensive drugs administration

antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

Group Type OTHER

antihypertensive drugs administration

Intervention Type PROCEDURE

continue antihypertensive medications

Interventions

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strict volume control policy

strict volume control by UF and dietary salt restriction

Intervention Type PROCEDURE

antihypertensive drugs administration

continue antihypertensive medications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* aged between 18-70 years old
* on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
* willingness to participate in the study with a written informed consent.

Exclusion Criteria

* to be scheduled for living donor renal transplantation
* to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ercan OK

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ercan Ok, M.D

Role: STUDY_CHAIR

Ege University School of Medicine Nephrology Department

Locations

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Adana Numune Research and Education Hospital

Adana, Adana, Turkey (Türkiye)

Site Status

Ege University School of Medicine Division of Nephrology

Bornova, İzmir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ege1336

Identifier Type: -

Identifier Source: org_study_id