Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Ercan OK, Ege University
ClinicalTrials.gov Identifier:
NCT00974857
First received: September 9, 2009
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Left Ventricular Hypertrophy
Device: BCM
Other: control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • Regression of left ventricular mass index (LVMI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in post-dialysis body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Achievement of normal blood pressure level without using anti-hypertensive medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Decrease in left atrial volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hematocrit and related rHu-EPO doses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum levels of albumin and Hs-CRP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Plasma level of pro-BNP [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

Device: 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.
Other Name: Body Composition Monitor,Fresenius Medical Care,Deutschland
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: 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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974857

Locations
Turkey
Ege University Division of Nephrology
Bornova, Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Fresenius Medical Care North America
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
  More Information

No publications provided

Responsible Party: Ercan OK, Professor, Ege University
ClinicalTrials.gov Identifier: NCT00974857     History of Changes
Other Study ID Numbers: 09-4/13
Study First Received: September 9, 2009
Last Updated: September 6, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Ege University:
Hemodialysis
Left Ventricular Hypertrophy
Body Composition Monitor

Additional relevant MeSH terms:
Hypertrophy
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014