Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
NCT ID: NCT00974857
Last Updated: 2013-09-09
Study Results
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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COMPLETED
PHASE4
126 participants
INTERVENTIONAL
2009-06-30
2010-09-30
Brief Summary
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Detailed Description
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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.
1. If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Study group
Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month.
1. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure.
2. 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
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.
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.
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.
Interventions
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BCM
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
* Willingness to participate in the study with a written informed consent.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fresenius Medical Care North America
INDUSTRY
Ege University
OTHER
Responsible Party
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Ercan OK
Professor
Principal Investigators
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Ercan Ok, MD
Role: STUDY_DIRECTOR
Ege University Division of Nephrology
Gulay Asci, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University Division of Nephrology
Ender Hur, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University Division of Nephrology
Locations
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Ege University Division of Nephrology
Bornova, İzmir, Turkey (Türkiye)
Countries
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Other Identifiers
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09-4/13
Identifier Type: -
Identifier Source: org_study_id