Clinical trial NCT01104909: How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
End Stage Renal Disease
Hemodialysis
Keywords: Dry weight
Blood Pressure
Chronic Kidney disease
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2010-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Diastolic and systolic blood pressure assessed by ABPM
timeFrame: after 2 weeks
Secondary outcomes:
measure: intradialytic signals and/or symptoms
timeFrame: during two weeks
Other outcomes:
Locations:
city: Carazinho
country: Brazil
facility: Darlan Martins Lara
state: Rio Grande do Sul
Study officials:
affiliation: Fedral University of Rio Grande do Sul
name: Darlan M Lara, MD MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Miguel Gus, MD PhD.
role: STUDY_CHAIR
References: