Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Condition: Left Ventricular Hypertrophy
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): BCM; control group
Intervention type(s): Device; Other
Intervention description(s): 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.; 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 name(s): Body Composition Monitor,Fresenius Medical Care,Deutschland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Hemodialysis; Left Ventricular Hypertrophy; Body Composition Monitor