Transdermal Clonidine in Chronic Hemodialysis Patients

NCT ID: NCT02545530

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Renal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

transdermal clonidine+

apply one transdermal clonidine(2.5mg) each week for 4 weeks besides regular antihypertensive agents, reduce oral antihypertensive agents' dosage or type if blood pressure decreased.

Group Type: ACTIVE_COMPARATOR

transdermal clonidine

Intervention Type: DRUG

2.5mg/patch per week

transdermal clonidine-

regular antihypertensive treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transdermal clonidine

2.5mg/patch per week

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Zuo

Head of department of nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zuo, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li ZUO, MD

Role: CONTACT

zuolimd@hotmail.com

+861088324008

Liangying Gan, MD

Role: CONTACT

ganl@bjmu.edu.cn

+861088324005

Facility Contacts

Li Zuo, MD

Role: primary

zuolimd@hotmail.com

+861088324008

Liangying Gan, MD

Role: backup

Ganl@bjmu.edu.cn

+861088324005

Other Identifiers

KLD2015.0203

Identifier Type: -

Identifier Source: org_study_id