Plain English Summary
Background and study aims
Dialysis is a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly. It often involves diverting blood to a machine to be cleaned. Normally, the kidneys filter the blood, removing harmful waste products and excess fluid and turning these into urine to be passed out of the body.
Studies have shown that dialysis patients can develop heart problems due to changes in nervous system activity.
The objective of the present study was to determine whether treatment with carvedilol can improve the symptoms of heart problems in patients on dialysis.
Who can participate?
Patients aged 18 years or above, with chronic kidney disease (CKD), having been on regular hemodialysis for more than 6 months.
What does the study involve?
Each patient was evaluated over a 14-day period. Hemodialysis was performed by medical staff who were unaware of the aim of the study. Patients and staff were both blinded to the additional treatment being administered: placebo on days 0 through 7; and carvedilol on days 8 through 14.
What are the possible benefits and risks of participating?
The benefit is better control of hypertension. The main risk is hypotension regarding the use of carvedilol.
Where is the study run from?
Mario Covas Hospital (Brazil)
When is the study starting and how long is it expected to run for?
October 2004 to August 2005
Who is funding the study?
The Brazilian National Council for Scientific and Technological Development (Brazil)
Who is the main contact?
Dr Joao Isuk Suh
joaoisuh@uol.com.br
Trial website
Contact information
Type
Scientific
Primary contact
Dr Joao Suh
ORCID ID
Contact details
Apto 81
Rua da Fonte 51
Santo Andre
09040270
Brazil
+55 11983819976
joaoisuh@uol.com.br
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
151 Effect
Study information
Scientific title
Effect of carvedilol on norepinephrine levels in hemodialysis patients: a prospective double-blind placebo-controlled clinical trial
Acronym
EFFECT
Study hypothesis
The objective of this unprecedented study was to determine whether the use of carvedilol correlates with norepinephrine levels in hemodialysis patients
Ethics approval
Approved 01/10/2004, ABC Medical School Research Ethics Committee (Lauro Gomes ave, 2000, Santo Andre, Sao Paulo, Brazil, 09060870; +55 1149935400; no email provided), ref 087/2004
Study design
Prospective interventional non-randomized placebo-controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular disease in hemodialysis patients
Intervention
This was a prospective study involving a cohort of stable patients recruited from eligible patients who were undergoing hemodialysis at the study centre hemodialysis clinic three times a week during the period of study
Each patient was evaluated over a 14-day period. Hemodialysis was performed by medical staff who were unaware of the aim of the study. Patients and staff were both blinded to the additional treatment being administered: placebo on days 0 through 7; and carvedilol on days 8 through 14. The carvedilol was given in increasing doses, from a minimum of 3.123 mg (twice a day) on day 8 to a maximum of 9.375 mg (twice a day) on day 14. Noninvasive (Holter) monitoring was performed on day 0 and on day 14. Plasma levels of norepinephrine were determined before and after hemodialysis on day 0 and day 14. Before and after hemodialysis on days 0, 7, and 14, patients completed a symptom questionnaire.
Intervention type
Drug
Phase
Not Applicable
Drug names
Carvedilol
Primary outcome measure
Mean plasma norepinephrine level measured by High Performance Liquid Chromatography (HPLC) at 0 and 14 days
Secondary outcome measures
Number of ventricular arrhythmias registered by Holter monitoring at 0 and 14 days
Overall trial start date
01/10/2004
Overall trial end date
01/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years or older
2. Having chronic kidney disease (CKD)
3. Having been on regular hemodialysis for more than 6 months
4. Having a hemoglobin level >10 mg/dl
5. Having a Kt/V >1.2 in more than three consecutive measures
6. Patients gave written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26
Total final enrolment
26
Participant exclusion criteria
1. Active liver disease
2. Any other decompensated disease
3. Previously used beta-blockers
4. Active infection
5. Hospitalized
Recruitment start date
01/12/2004
Recruitment end date
01/07/2005
Locations
Countries of recruitment
Brazil
Trial participating centre
Mario Covas Hospital
Henrique Calderazzo street 321
Santo Andre
Sao Paulo
09190615
Brazil
Sponsor information
Organisation
University of Sao Paulo
Sponsor details
Teodoro Sampaio Street 115
São Paulo
05405000
Brazil
+55 1130618203
angelica.belem@hc.fm.usp.br
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Alternative name(s)
National Council for Scientific and Technological Development, CNPq
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
2008 results published in thesis https://teses.usp.br/teses/disponiveis/5/5159/tde-05082008-135611/publico/joaoisuksuh.pdf
IPD sharing statement:
All data, comments, informed consent model, and statistical analysis are available to the public permanently at the weblink above in the form of a monograph, or are available from the corresponding author on reasonable request.
Intention to publish date
01/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list