- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974857
Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Izmir
-
Bornova, Izmir, Turkey, 35100
- Ege University Division of Nephrology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Study group
Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month.
If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation. |
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.
Other Names:
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression of left ventricular mass index (LVMI)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in post-dialysis body weight
Time Frame: 1 year
|
1 year
|
Achievement of normal blood pressure level without using anti-hypertensive medication
Time Frame: 1 year
|
1 year
|
Decrease in left atrial volume
Time Frame: 1 year
|
1 year
|
Hematocrit and related rHu-EPO doses
Time Frame: 1 year
|
1 year
|
Serum levels of albumin and Hs-CRP
Time Frame: 1 year
|
1 year
|
Plasma level of pro-BNP
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ercan Ok, MD, Ege University Division of Nephrology
- Principal Investigator: Gulay Asci, MD, Ege University Division of Nephrology
- Principal Investigator: Ender Hur, MD, Ege University Division of Nephrology
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-4/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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