End Stage Renal Disease on Dialysis, Intradialytic Hypotension
Conditions
Brief summary
To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM
Interventions
DRUGCHM intervention group
Jia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks
OTHERNo CHM treatment
The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Maintenance bicarbonate hemodialysis (HD) for more than 1 year, three times a week 3.5 to 4.5 h HD schedule. * Have experienced more than 30% episodes of IDH (defined as a systolic BP\<90 mmHg on dialysis or requirement for clinical intervention) during the exposure assessment period (months 1-3) of this study * Cognitive ability to give written informed consent.
Exclusion criteria
* Allergic history to Chinese herbal medicine * Systemic diseases such as coagulation disorders, malignancy, liver diseases and cardiovascular diseases. * Estimated survival time \< 1 year. * Mental illness. * Participate in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intradialytic hypotension (IDH) epidose | week 1 to 8 | IDH episode was record on every dialysis session, account for 24 dialysis sessions. ( IDH was defined as a nadir SBP of \< 90 mmHg or requirement for clinical intervention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic blood pressure (BP) measurement | week 1 to 8 | Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session. |
| Pharmacotherapy | week 1 to 8 | Frequent and dose in mg of vasopressor agents at each session |
| Kidney Disease and Quality of Life-36 (KDQOL-36) | week 1 and 8 | The Taiwanese version of the. KDQOL-36 questionnaire is reliable and valid for evaluating the quality of life in dialysis patients. It includes 12 items that provide a generic chronic disease core (i.e., the SF-12, a shorter version of the SF-36), as well as 24 additional items (i.e., kidney-disease-targeted items). The 24 additional items focus on particular health-related concerns of individuals with kidney disease (i.e., symptom/problem list, 12 items; effects of kidney disease, 8 items; and burden of disease, 4 items).KDQOL-36 subscale scores ranged from 0 to 100, and lower scores indicated worse self-reported quality of life. |
Countries
Taiwan
Contacts
CONTACTMing-Yen Tsai, PhD
Outcome results
None listed