Intradialytic Hypotension
Conditions
Keywords
Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao
Brief summary
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.
Interventions
DRUGGui-Lu-Er-Xian-Jiao-Wan
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* End stage renal disease treated with hemodialysis for ≥3 months * Receive a standard thrice-weekly hemodialysis schedule * More than 25% of hemodialysis sessions complicated by intradialytic hypotension
Exclusion criteria
* Active malignancy * Life-threatening conditions * Pregnancy * Recent participation in another clinical trial for intradialytic hypotension * History of hypersensitivity or contraindication to herbal medicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic hypotension episode | Each time of dialysis during 12-weeks study period. | Hypotension episode during hemodialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early termination of hemodialysis | Each time of dialysis during 12-weeks study period. | The episode of early termination in hemodialysis due to hypotension |
| SF-36 | Baseline, 12 weeks, 28 weeks | Short Form (36) Health Survey (SF-36) |
Countries
Taiwan
Contacts
Primary ContactChun-Ting Liu
Outcome results
None listed