Advertisement

Topics

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

2014-08-27 03:19:25 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Conditions

Hemodialysis

Intervention

BCM

Location

Ege University Division of Nephrology
Bornova
Izmir
Turkey
35100

Status

Active, not recruiting

Source

Ege University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:25-0400

Clinical Trials [430 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basi...

A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416

This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodial...

Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis

Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality...

A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease

The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney di...

The Efficacy of Hemoperfusion Combined With Hemodialysis in Improving the Survival of MHD Patients

This multi-center, open-label, randomized, parallel group study aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and...

PubMed Articles [367 Associated PubMed Articles listed on BioPortfolio]

Hemodialysis Water Parameters as Predisposing Factors for Anemia in Patients in Dialytic Treatment: Application of Mixed Regression Models.

Contamination by metals and microbiological agents in hemodialysis water can cause clinical intercurrences in hemodialysis patients. Evaluating and assuring minimum levels of contamination from metals...

Targets and Therapeutics for Glycemic Control in Diabetes Patients on Hemodialysis.

For diabetes patients without nephropathy, glycemic control is important to reduce the risk or delay the progression of diabetes complications, including nephropathy. In diabetes patients on hemodialy...

Salt Intake and All-Cause Mortality in Hemodialysis Patients.

Although some clinical practice guidelines regarding hemodialysis recommend salt restriction, few studies have examined the association between salt intake and clinical outcomes in hemodialysis patien...

From Isonatric to Isotonic Hemodialysis.

Isonatric hemodialysis aims at maintaining stable cellular hydration through a close control of natremia, considered a surrogate of tonicity. However, 2 methods are available to perform isonatric hemo...

Patient Reported Improvement in Quality of Life Associated With Successful Laser Hair Reduction at Hemodialysis Site With 1064-nm Nd:YAG Laser.

Laser hair reduction is a well-established modality for a wide range of medical indications. Laser hair reduction can be beneficial for hemodialysis patients who undergo repeated adhesive tape applica...

Medical and Biotech [MESH] Definitions

Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.

Long-term maintenance hemodialysis in the home.

The combination of hemodialysis and hemofiltration either simultaneously or sequentially. Convective transport (hemofiltration) may be better for removal of larger molecular weight substances and diffusive transport (hemodialysis) for smaller molecular weight solutes.

Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).

Extracorporeal ultrafiltration technique without hemodialysis for treatment of fluid overload and electrolyte disturbances affecting renal, cardiac, or pulmonary function.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...


Searches Linking to this Trial