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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; End Stage Renal Disease; Blood Pressure
• Intervention / Treatment: Procedure: Clinical; Device: electrical bioimpedance

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Carazinho, Rio Grande do Sul, Brazil, 99500-000
      • Darlan Martins Lara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical dry weight; Group which the dry weight will be assessed based on clinical examination.	Procedure: Clinical; Each patient will be submitted a clinical evaluation, considering signals of overload.
Active Comparator: Bioimpedance; Group which the dry weight will be assessed by bioimpedance data.	Device: electrical bioimpedance; From electrical bioimpedance data, will be fixed a revised dry weight for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade de Passo Fundo
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Darlan M Lara, MD MsC, Fedral University of Rio Grande do Sul; Study Chair: Miguel Gus, MD PhD., Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 14, 2010
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Blood Pressure; Chronic Kidney disease; Dry weight
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: DryWeightESRDxBloodPressure; ESRD; BLOOD PRESSURE; Dry weight