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Clinical Trials/NCT01104909
NCT01104909
Completed
Not Applicable

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

Universidade de Passo Fundo1 site in 1 country100 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Universidade de Passo Fundo
Enrollment
100
Locations
1
Primary Endpoint
Diastolic and systolic blood pressure assessed by ABPM
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidade de Passo Fundo

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • intradialytic signals and/or symptoms(during two weeks)

Study Sites (1)

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