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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by:
Universidade de Passo Fundo
ClinicalTrials.gov Identifier:
NCT01104909
First received: April 13, 2010
Last updated: April 14, 2010
Last verified: April 2008
  Purpose

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.


Condition Intervention
Blood Pressure
End Stage Renal Disease
Hemodialysis
Procedure: Clinical
Device: electrical bioimpedance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Universidade de Passo Fundo:

Primary Outcome Measures:
  • Diastolic and systolic blood pressure assessed by ABPM [ Time Frame: after 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • intradialytic signals and/or symptoms [ Time Frame: during two weeks ] [ Designated as safety issue: Yes ]
    the intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight


Estimated Enrollment: 100
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104909

Locations
Brazil
Darlan Martins Lara
Carazinho, Rio Grande do Sul, Brazil, 99500-000
Sponsors and Collaborators
Universidade de Passo Fundo
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
  More Information

No publications provided

Responsible Party: Darlan Martins Lara, Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01104909     History of Changes
Other Study ID Numbers: DryWeightESRDxBloodPressure, ESRD, Blood Pressure, Dry weight
Study First Received: April 13, 2010
Last Updated: April 14, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade de Passo Fundo:
Dry weight
Blood Pressure
Chronic Kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014