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Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients

Primary Purpose

Left Ventricular Hypertrophy

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
BCM
control group
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Left Ventricular Hypertrophy focused on measuring Hemodialysis, Left Ventricular Hypertrophy, Body Composition Monitor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 18-year,
  • Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
  • Willingness to participate in the study with a written informed consent.

Exclusion Criteria:

  • Presence of a cardiac stent, pacemaker or defibrillator ,
  • Artificial joints, pin or amputation
  • Permanent or temporary catheters (may affect BCM measurement),
  • Being scheduled for living donor renal transplantation,
  • Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
  • Pregnancy or lactating,
  • Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
  • Mental incompetence.

Sites / Locations

  • Ege University Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Study group

Control Group

Arm Description

Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure. If OH is negative and: Systolic blood pressure(SBP)< 100 mmHg with/or intradialytic hypotension episodes(IDHE) and/or clothing and/or erythrocytosis(htc>36%);dry weight will be increased. SBP normal(100-150 mmHg) w/o IDHE and clothing and erythrocytosis;dry weight will not be changed. SBP normal(100-150 mmHg) with IDHE and/or clothing and/or erythrocytosis;dry weight will be increased. SBP>150 mmHg captopril test(CT)will be done. If CT is positive, ACEI/ ARBs will be used and dry weight will be increased if IDHE and/or clothing and/or erythrocytosis(htc>36%) are present. If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation.

BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.

Outcomes

Primary Outcome Measures

Regression of left ventricular mass index (LVMI)

Secondary Outcome Measures

Changes in post-dialysis body weight
Achievement of normal blood pressure level without using anti-hypertensive medication
Decrease in left atrial volume
Hematocrit and related rHu-EPO doses
Serum levels of albumin and Hs-CRP
Plasma level of pro-BNP

Full Information

First Posted
September 9, 2009
Last Updated
September 6, 2013
Sponsor
Ege University
Collaborators
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT00974857
Brief Title
Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Official Title
Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.
Detailed Description
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group. In the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight. If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure. If OH is negative value , and: Systolic blood pressure is < 100 mmHg with/or intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %); we will increase dry weight accordingly. Systolic blood pressure is normal (100-150 mmHg) without intradialytic hypotension episodes and clothing and erythrocytosis; we will not change dry weight. Systolic blood pressure normal (100-150 mmHg) with intradialytic hypotension episodes and/or clothing and/or erythrocytosis; we will increase dry weight. Systolic blood pressure> 150 mmHg we will perform a captopril test (CT) If the CT is positive we will use ACE inhibitors / ARBs as anti hypertensive drugs and dry weight will be increased if intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %) are also present If the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation. We will not need to reach the dry weight immediately. If severe BP drop precludes reaching DW in one session, an isolated ultrafiltration or additional dialysis session will be added. In the control group, BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. The planned duration of the study is 12 months. All patients will be seen in every month during the study. Additional visits will be scheduled if any symptoms and intolerance are suspected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Hypertrophy
Keywords
Hemodialysis, Left Ventricular Hypertrophy, Body Composition Monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure. If OH is negative and: Systolic blood pressure(SBP)< 100 mmHg with/or intradialytic hypotension episodes(IDHE) and/or clothing and/or erythrocytosis(htc>36%);dry weight will be increased. SBP normal(100-150 mmHg) w/o IDHE and clothing and erythrocytosis;dry weight will not be changed. SBP normal(100-150 mmHg) with IDHE and/or clothing and/or erythrocytosis;dry weight will be increased. SBP>150 mmHg captopril test(CT)will be done. If CT is positive, ACEI/ ARBs will be used and dry weight will be increased if IDHE and/or clothing and/or erythrocytosis(htc>36%) are present. If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation.
Arm Title
Control Group
Arm Type
Other
Arm Description
BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
Intervention Type
Device
Intervention Name(s)
BCM
Other Intervention Name(s)
Body Composition Monitor,Fresenius Medical Care,Deutschland
Intervention Description
Overhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
Primary Outcome Measure Information:
Title
Regression of left ventricular mass index (LVMI)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in post-dialysis body weight
Time Frame
1 year
Title
Achievement of normal blood pressure level without using anti-hypertensive medication
Time Frame
1 year
Title
Decrease in left atrial volume
Time Frame
1 year
Title
Hematocrit and related rHu-EPO doses
Time Frame
1 year
Title
Serum levels of albumin and Hs-CRP
Time Frame
1 year
Title
Plasma level of pro-BNP
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18-year, Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week), Willingness to participate in the study with a written informed consent. Exclusion Criteria: Presence of a cardiac stent, pacemaker or defibrillator , Artificial joints, pin or amputation Permanent or temporary catheters (may affect BCM measurement), Being scheduled for living donor renal transplantation, Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease, Pregnancy or lactating, Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial, Mental incompetence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Ok, MD
Organizational Affiliation
Ege University Division of Nephrology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gulay Asci, MD
Organizational Affiliation
Ege University Division of Nephrology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ender Hur, MD
Organizational Affiliation
Ege University Division of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Division of Nephrology
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients

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