Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Information source: Ege University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Left Ventricular Hypertrophy
Intervention: BCM (Device); control group (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Ege University Official(s) and/or principal investigator(s): Ercan Ok, MD, Study Director, Affiliation: Ege University Division of Nephrology Gulay Asci, MD, Principal Investigator, Affiliation: Ege University Division of Nephrology Ender Hur, MD, Principal Investigator, Affiliation: Ege University Division of Nephrology
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.
Clinical Details
Official title: Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Primary outcome: Regression of left ventricular mass index (LVMI)
Secondary outcome: Changes in post-dialysis body weightAchievement 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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Ege University Division of Nephrology, Bornova, Izmir 35100, Turkey
Additional Information
Starting date: June 2009
Last updated: September 6, 2013
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