Clinical trial NCT00974857: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Left Ventricular Hypertrophy
Keywords: Hemodialysis
Left Ventricular Hypertrophy
Body Composition Monitor
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
First posted: 2009-09-10
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: Regression of left ventricular mass index (LVMI)
timeFrame: 1 year
Secondary outcomes:
measure: Changes in post-dialysis body weight
timeFrame: 1 year
measure: Achievement of normal blood pressure level without using anti-hypertensive medication
timeFrame: 1 year
measure: Decrease in left atrial volume
timeFrame: 1 year
measure: Hematocrit and related rHu-EPO doses
timeFrame: 1 year
measure: Serum levels of albumin and Hs-CRP
timeFrame: 1 year
measure: Plasma level of pro-BNP
timeFrame: 1 year
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University Division of Nephrology
state: Izmir
Study officials:
affiliation: Ege University Division of Nephrology
name: Ercan Ok, MD
role: STUDY_DIRECTOR
affiliation: Ege University Division of Nephrology
name: Gulay Asci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Division of Nephrology
name: Ender Hur, MD
role: PRINCIPAL_INVESTIGATOR
References: