How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
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|ClinicalTrials.gov Identifier: NCT01104909|
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : April 16, 2010
End-stage renal disease (ESRD) is a common clinical condition. In this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome.
The first step for a good control of blood pressure in renal patients is adjusting his/her dry weight. Actually, dry weight is assessed based on clinical examination and blood pressure.
The electrical bioimpedance is a simple and portable device. The investigators design a randomized clinical trial for evaluating two ways of getting the best dry weight for hemodialysis patients.
A basal 24h ABPM will be taken before the randomization. Then, 2 weeks later the dry weight be revised, the investigators will get a second 24h ABPM.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure End Stage Renal Disease Hemodialysis||Procedure: Clinical Device: electrical bioimpedance||Not Applicable|
End-stage renal disease (ESRD) is a common clinical condition over the world. In this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome.
The first step for a good control of blood pressure is giving a dry weight for the patient. We can understand dry weight or target weight as that one which the patient feels comfortable and there aren't clinical signals of volemic overload as edema, dyspnea, orthopnea, jugular turgency, hepatomegalia. Classically, the dry weight is assessed based on clinical examination, blood pressure and experience of hemodialysis staff.
The electrical bioimpedance is a very simple method that possibilities access the corporal compartments, including the body water, using a small and not expensive portable device.
Trying to study new forms for getting the ideal dry weight, we design a randomized clinical trial for evaluating two ways of getting a dry weight for hemodialysis patients.
One group will be dry weight fixed by bioimpedance data and in another group the dry weight will by a clinical protocol.
We will take a 24h ABPM basal from all patients before the randomization. Then, 2 weeks later the dry weight be revised, a second ABPM will be taken. The results will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Clinical Trial Evaluating Different Protocols for Improving the Way of Getting the Best Dry Weight for Hemodialysis Patients, Looking for Blood Pressure Control, Measured by ABPM|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||January 2010|
Active Comparator: Clinical dry weight
Group which the dry weight will be assessed based on clinical examination.
Each patient will be submitted a clinical evaluation, considering signals of overload.
Active Comparator: Bioimpedance
Group which the dry weight will be assessed by bioimpedance data.
Device: electrical bioimpedance
From electrical bioimpedance data, will be fixed a revised dry weight for each patient.
- Diastolic and systolic blood pressure assessed by ABPM [ Time Frame: after 2 weeks ]A basal measure will be taken at the start point. Then, the dry weight will be evaluated by clinical or BIA method. After 2 weeks of tree times-week sections of hemodialysis under the revised dry weight, a second measure of ABPM will be performed.
- intradialytic signals and/or symptoms [ Time Frame: during two weeks ]the intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104909
|Darlan Martins Lara|
|Carazinho, Rio Grande do Sul, Brazil, 99500-000|
|Principal Investigator:||Darlan M Lara, MD MsC||Fedral University of Rio Grande do Sul|
|Study Chair:||Miguel Gus, MD PhD.||Federal University of Rio Grande do Sul|