How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
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Purpose
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 | Intervention |
|---|---|
|
Blood Pressure End Stage Renal Disease Hemodialysis |
Procedure: Clinical Device: electrical bioimpedance |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Diastolic and systolic blood pressure assessed by ABPM [ Time Frame: after 2 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]the intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Clinical dry weight
Group which the dry weight will be assessed based on clinical examination.
|
Procedure: Clinical
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with ESRD, clinically stable, under hemodialysis therapy at two clinics in the North of Rio Grande do Sul.
Exclusion Criteria:
- Clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).
Contacts and Locations| Brazil | |
| 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 |
More Information
No publications provided
| Responsible Party: | Darlan Martins Lara, Universidade Federal do Rio Grande do Sul |
| ClinicalTrials.gov Identifier: | NCT01104909 History of Changes |
| Other Study ID Numbers: | DryWeightESRDxBloodPressure, ESRD, Blood Pressure, Dry weight |
| Study First Received: | April 13, 2010 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade de Passo Fundo:
|
Dry weight Blood Pressure Chronic Kidney disease |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013