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Completed

NCT Number: NCT01104909

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Clinical

Procedure

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

electrical bioimpedance

Device

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Apr 16, 2010
Registry last updated
Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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