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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104909
• Other study ID #: DryWeightESRDxBloodPressure
• Secondary ID: ESRDBlood Pressu
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 14, 2010
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2008
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blood Pressure
• End Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• Clinical
Each patient will be submitted a clinical evaluation, considering signals of overload.

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

Locations

Country	Name	City	State
Brazil	Darlan Martins Lara	Carazinho	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Universidade de Passo Fundo	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic and systolic blood pressure assessed by ABPM	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.	after 2 weeks	Yes
Secondary	intradialytic signals and/or symptoms	the intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight	during two weeks	Yes