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

NCT00974857 | Completed Phase 4 DMC

• 1 other identifier: 09-4/13
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Hypertrophy

Keywords

Hemodialysis; Left Ventricular Hypertrophy; Body Composition Monitor

Outcome Measures

Primary Outcomes (1)

• Regression of left ventricular mass index (LVMI)

  1 year

Secondary Outcomes (6)

• Changes in post-dialysis body weight

  1 year

• Achievement of normal blood pressure level without using anti-hypertensive medication

  1 year

• Decrease in left atrial volume

  1 year

• Hematocrit and related rHu-EPO doses

  1 year

• Serum levels of albumin and Hs-CRP

  1 year

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Control Group

OTHER

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

Interventions

BCM DEVICE

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.

Also known as: Body Composition Monitor,Fresenius Medical Care,Deutschland

Study group

control group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead
• Fresenius Medical Care North America: collaborator

Study Sites (1)

Ege University Division of Nephrology

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ercan Ok, MD

  Ege University Division of Nephrology

  STUDY DIRECTOR

• Gulay Asci, MD

  Ege University Division of Nephrology

  PRINCIPAL INVESTIGATOR

• Ender Hur, MD

  Ege University Division of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

TU (1)