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

NCT ID: NCT01104909

Last Updated: 2010-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-01-31

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.

Conditions

Blood Pressure; End Stage Renal Disease; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Clinical dry weight

Group which the dry weight will be assessed based on clinical examination.

Group Type: ACTIVE_COMPARATOR

Clinical

Intervention Type: PROCEDURE

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

Bioimpedance

Group which the dry weight will be assessed by bioimpedance data.

Group Type: ACTIVE_COMPARATOR

electrical bioimpedance

Intervention Type: DEVICE

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

Interventions

Clinical

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

Intervention Type: PROCEDURE

electrical bioimpedance

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Universidade de Passo Fundo

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal do Rio Grande do Sul

Principal Investigators

Darlan M Lara, MD MsC

Role: PRINCIPAL_INVESTIGATOR

Fedral University of Rio Grande do Sul

Miguel Gus, MD PhD.

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Locations

Darlan Martins Lara

Carazinho, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

ESRD

Identifier Type: -

Identifier Source: secondary_id

Blood Pressure

Identifier Type: -

Identifier Source: secondary_id

Dry weight

Identifier Type: -

Identifier Source: secondary_id

DryWeightESRDxBloodPressure

Identifier Type: -

Identifier Source: org_study_id