Effect of carvedilol on norepinephrine levels in hemodialysis patients
| ISRCTN | ISRCTN16564394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16564394 |
| Secondary identifying numbers | 151 Effect |
- Submission date
- 27/08/2020
- Registration date
- 02/09/2020
- Last edited
- 01/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Apto 81
Rua da Fonte 51
Santo Andre
09040270
Brazil
| Phone | +55 11983819976 |
|---|---|
| joaoisuh@uol.com.br |
Study information
| Study design | Prospective interventional non-randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of carvedilol on norepinephrine levels in hemodialysis patients: a prospective double-blind placebo-controlled clinical trial |
| Study acronym | EFFECT |
| Study objectives | The objective of this unprecedented study was to determine whether the use of carvedilol correlates with norepinephrine levels in hemodialysis patients |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2004 |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 26 |
| Total final enrolment | 26 |
| Key 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 |
| Key exclusion criteria | 1. Active liver disease 2. Any other decompensated disease 3. Previously used beta-blockers 4. Active infection 5. Hospitalized |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Santo Andre
Sao Paulo
09190615
Brazil
Sponsor information
University/education
Teodoro Sampaio Street 115
São Paulo
05405000
Brazil
| Phone | +55 1130618203 |
|---|---|
| angelica.belem@hc.fm.usp.br | |
| Website | http://www5.usp.br/en/ |
"ROR" |
https://ror.org/036rp1748 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Brazilian National Council for Research and Development, National Council for Scientific and Technological Development, CNPq
- Location
- Brazil
Results and Publications
| Intention to publish date | 01/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
