Renal Dialysis
Conditions
Keywords
renal dialysis, hypertension, clonidine
Brief summary
The majority of chronic hemodialysis patients need a combination of several antihypertensive drugs for adequate BP control. The primary objective of this study is to evaluate whether transdermal clonidine can improve blood pressure control or decrease oral antihypertensive agents type or dosage and the secondary objective is to observe incidence of adverse reactions of transdermal clonidine in chronic hemodialysis patients.
Detailed description
It's a randomised crossover clinical trial. Subjects: chronic hemodialysis patients. All subjects will be randomised to 2 groups. Subjects in first group will receive 4 weeks transdermal clonidine plus regular antihypertensive agents treatments first, 2weeks wash-out then and 4 weeks antihypertensive agents without transdermal clonidine. The other group will receive 4 weeks antihypertensive agents without transdermal clonidine first, 2weeks wash-out then and 4 weeks transdermal clonidine plus regular antihypertensive agents treatments. Ambulatory blood pressure, echocardiography, and biochemistry will be detected.
Interventions
DRUGtransdermal clonidine
2.5mg/patch per week
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. signed informed consent; 2. age: 18years to 80 years old； 3. on hemodialysis for more than or equal to 3 months, not less than 3 times and 12 hours hemodialysis per week； 4. cardiac function grade I or grade II(NYHA)； 5. Using 1 or more than 1 oral antihypertensive drugs, pre-dialysis systolic blood pressure over 140mmHg or dialysis blood pressure over 90mmHg, post-dialysis systolic blood pressure over 130mmHg or diastolic blood pressure over 80mmHg
Exclusion criteria
1. acute infection within 1 month； 2. acute myocardial infarction/cardiac function grade IV/stroke within 3months； 3. LVEF lower than 50% by echocardiography； 4. Dry weight is not suitable by BCM evaluation, more than plus or minus 1kg； 5. Inter-dialysis weight gain exceeds 5% of dry weight； 6. Post-dialysis systolic blood pressure lower than 120mmHg and diastolic blood pressure lower than 70mmHg； 7. Begin or stop recombinant human erythropoietin treatment within 2 weeks before inclusion or 10 weeks after inclusion; 8. Adjust recombinant human erythropoietin dosage to more than 2times or less than half original dosage within 2 weeks before inclusion or 10 weeks after inclusion； 9. The treatment regimen will be amended within 10 weeks and it is expected that the treatment amendment may affect blood pressure； 10. Pregnancy or lactation or planning a pregnancy in 10 weeks； 11. Expected to withdraw hemodialysis treatment in 10 weeks； 12. Allergic to clonidine or its accessories； 13. Undergoing other clinical studies, and the research interventions have an impact on blood pressure； 14. Other clinical conditions that may affect the results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of blood pressure and oral antihypertensive agents' dosage and type | 4 weeks | mmHg of MAP decreased, changes of total antihypertensive agents' DDD and changes of total antihypertensive agents' types |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse effects compared with control group | 4 weeks |
Countries
China
Contacts
Primary ContactLi ZUO, MD
Backup ContactLiangying Gan, MD
Outcome results
None listed