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

Primary Purpose

Blood Pressure, End Stage Renal Disease, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Clinical
electrical bioimpedance
Sponsored by
Universidade de Passo Fundo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Pressure focused on measuring Dry weight, Blood Pressure, Chronic Kidney disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Darlan Martins Lara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clinical dry weight

Bioimpedance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2010
Last Updated
April 14, 2010
Sponsor
Universidade de Passo Fundo
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01104909
Brief Title
How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade de Passo Fundo
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, End Stage Renal Disease, Hemodialysis
Keywords
Dry weight, Blood Pressure, Chronic Kidney disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical dry weight
Arm Type
Active Comparator
Arm Description
Group which the dry weight will be assessed based on clinical examination.
Arm Title
Bioimpedance
Arm Type
Active Comparator
Arm Description
Group which the dry weight will be assessed by bioimpedance data.
Intervention Type
Procedure
Intervention Name(s)
Clinical
Intervention Description
Each patient will be submitted a clinical evaluation, considering signals of overload.
Intervention Type
Device
Intervention Name(s)
electrical bioimpedance
Intervention Description
From electrical bioimpedance data, will be fixed a revised dry weight for each patient.
Primary Outcome Measure Information:
Title
Diastolic and systolic blood pressure assessed by ABPM
Description
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.
Time Frame
after 2 weeks
Secondary Outcome Measure Information:
Title
intradialytic signals and/or symptoms
Description
the intradialytic signals and/or symptoms will be assessed by dialysis registers, before and after de revision of dry weight
Time Frame
during two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darlan M Lara, MD MsC
Organizational Affiliation
Fedral University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Gus, MD PhD.
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Chair
Facility Information:
Facility Name
Darlan Martins Lara
City
Carazinho
State/Province
Rio Grande do Sul
ZIP/Postal Code
99500-000
Country
Brazil

12. IPD Sharing Statement

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

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