Blood PressureNCT01104909
How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
A study testing Clinical and electrical bioimpedance in people with Blood Pressure and End Stage Renal Disease, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Clinical and electrical bioimpedance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ESRD, clinically stable, under hemodialysis therapy at two clinics in the North of Rio Grande do Sul.
Who cannot join
- Clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Clinical, electrical bioimpedance
- Keywords
- Dry weight, Blood Pressure, Chronic Kidney disease
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinicalProcedure or surgery
Each patient will be submitted a clinical evaluation, considering signals of overload.
electrical bioimpedanceDevice
From electrical bioimpedance data, will be fixed a revised dry weight for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Clinical dry weight | Active comparator | Group which the dry weight will be assessed based on clinical examination. Receives: Procedure: Clinical |
| Bioimpedance | Active comparator | Group which the dry weight will be assessed by bioimpedance data. Receives: Device: electrical bioimpedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 2 weeks
Secondary outcomes (1)
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
Measured: during two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2008
- Primary completionMay 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Investigators
- Darlan M Lara, MD MsC, Principal investigator, Fedral University of Rio Grande do SulMiguel Gus, MD PhD., Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104909
- Sponsor's protocol ID
- DryWeightESRDxBloodPressure
- Other IDs
- ESRD, Blood Pressure, Dry weight
- Status last verified
- Apr 2008
- First submitted
- 13 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01104909
- Acronym / sponsor ID
- DryWeightESRDxBloodPressure
- Conditions
- Blood Pressure, End Stage Renal Disease, Hemodialysis
- Keywords
- Dry weight, Blood Pressure, Chronic Kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Apr 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical dry weight | Active comparator | Procedure: ClinicalGroup which the dry weight will be assessed based on clinical examination. |
| Bioimpedance | Active comparator | Device: electrical bioimpedanceGroup which the dry weight will be assessed by bioimpedance data. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ESRD, clinically stable, under hemodialysis therapy at two clinics in the North of Rio Grande do Sul.
Key exclusion criteria (1 listed)
- Clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClinicalEach patient will be submitted a clinical evaluation, considering signals of overload. | Procedure or surgery | Clinical dry weight |
| electrical bioimpedanceFrom electrical bioimpedance data, will be fixed a revised dry weight for each patient. | Device | Bioimpedance |
Primary outcome
Diastolic and systolic blood pressure assessed by ABPM
Time frame: after 2 weeks
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.
1 secondary outcome
intradialytic signals and/or symptoms
Time frame: during two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
Related trials for Blood Pressure
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingPhase 3
A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity
Hypertension, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darlan M Lara, MD MsC principal investigator
Fedral University of Rio Grande do Sul
Miguel Gus, MD PhD. study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and electrical bioimpedance in people with Blood Pressure and End Stage Renal Disease, run by Universidade de Passo Fundo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic and systolic blood pressure assessed by ABPM (time frame: after 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2010.