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

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
strict volume control policy
antihypertensive drugs administration
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring end-stage renal disease, hemodialysis, volume control, ultrafiltration, inflammation, cardiovascular disease, left ventricular hypertrophy, dietary salt restriction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege University School of Medicine Division of Nephrology
  • Adana Numune Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

strict volume control policy

antihypertensive drugs administration

Arm Description

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

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

Outcomes

Primary Outcome Measures

regression of left ventricular hypertrophy
regression of left ventricular mass
change in left ventricular end-diastolic volume

Secondary Outcome Measures

change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels

Full Information

First Posted
March 27, 2006
Last Updated
September 6, 2013
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT00307463
Brief Title
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
Official Title
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
end-stage renal disease, hemodialysis, volume control, ultrafiltration, inflammation, cardiovascular disease, left ventricular hypertrophy, dietary salt restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strict volume control policy
Arm Type
Active Comparator
Arm Description
strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
Arm Title
antihypertensive drugs administration
Arm Type
Other
Arm Description
antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.
Intervention Type
Procedure
Intervention Name(s)
strict volume control policy
Intervention Description
strict volume control by UF and dietary salt restriction
Intervention Type
Procedure
Intervention Name(s)
antihypertensive drugs administration
Intervention Description
continue antihypertensive medications
Primary Outcome Measure Information:
Title
regression of left ventricular hypertrophy
Time Frame
one year
Title
regression of left ventricular mass
Time Frame
one year
Title
change in left ventricular end-diastolic volume
Time Frame
one year
Secondary Outcome Measure Information:
Title
change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Ok, M.D
Organizational Affiliation
Ege University School of Medicine Nephrology Department
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University School of Medicine Division of Nephrology
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Adana Numune Research and Education Hospital
City
Adana
ZIP/Postal Code
01100
Country
Turkey

12. IPD Sharing Statement

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

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