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How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104909
Enrollment
100
Registered
2010-04-16
Start date
2008-04-30
Completion date
2010-01-31
Last updated
2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, End Stage Renal Disease, Hemodialysis

Keywords

Dry weight, Blood Pressure, Chronic Kidney disease

Brief summary

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.

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.

Interventions

PROCEDUREClinical

Each patient will be submitted a clinical evaluation, considering signals of overload.

From electrical bioimpedance data, will be fixed a revised dry weight for each patient.

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Universidade de Passo Fundo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Diastolic and systolic blood pressure assessed by ABPMafter 2 weeksA 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.

Secondary

MeasureTime frameDescription
intradialytic signals and/or symptomsduring two weeksthe intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026