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

NCT01104909 | Completed DMC

• 4 other identifiers: DryWeightESRDxBloodPressureESRDBlood PressureDry weight
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; End Stage Renal Disease; Hemodialysis

Keywords

Dry weight; Blood Pressure; Chronic Kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intradialytic signals and/or symptoms

  during two weeks

Study Arms (2)

Clinical dry weight

ACTIVE COMPARATOR

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

Procedure: Clinical

Bioimpedance

ACTIVE COMPARATOR

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

Device: electrical bioimpedance

Interventions

Clinical PROCEDURE

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

Clinical dry weight

electrical bioimpedance DEVICE

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

Bioimpedance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ESRD, clinically stable, under hemodialysis therapy at two clinics in the North of Rio Grande do Sul.

You may not qualify if:

• Clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).

Sponsors & Collaborators

• Universidade de Passo Fundo: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Darlan Martins Lara

Carazinho, Rio Grande do Sul, 99500-000, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darlan M Lara, MD MsC

  Fedral University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Miguel Gus, MD PhD.

  Federal University of Rio Grande do Sul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: January 1, 2010
• Last Updated: April 16, 2010

Record last verified: 2008-04

Locations

BR (1)