Septic Shock
Conditions
Keywords
septic shock, shock reversal, ICU, traditional Chinese medicine
Brief summary
The purpose of this study is to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.
Detailed description
Those with hemodynamic instability were the main population of the ICU patients, whether the exact etiology leading to the diseases. However, how to maintain adequate hemodynamic status in order to keep the patients with well organs perfusion is the main issue of the intensive care physicians. The choices of vasoactive drugs in the guidelines or experts' suggestions nowadays used are still limited in the western medicine. Si-Ni-Tang, a remedy previously used in ancient China and now widely prescribed in Taiwan and China, is used for treating patients diagnosed as shock or heart failure. The investigators are eager to know if there existed any benefit via adding this drug to treat the septic shock patients. Therefore, the investigators designed a prospectively randomized double blind control trial to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.
Interventions
DRUGSi-Ni-Tang/ Placebo of Si-Ni-Tang
The prescription is 2.25 grams four times a day ( 9 grams per day) for 7 days or till shock reversal( if shock reversal \< 1 week). Shock reversal was defined as the discontinuation of norepinephrine or dopamine lasting for at least 24 hours.
Sponsors
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to our intensive care units are enrolled if their disease diagnosis meets the definition of septic shock * Using vasopressor now and the duration from initiation of vasopressor use to the entrance of the study is within 24 hours * Nasogastric tube feeding
Exclusion criteria
* More than one kind of vasopressor is administrated * Patients with extremely poor gastrointestinal function and can not tolerate diet feeding * Acute myocardial infarction * Patients with evidence of major bleeding * Expected surgical intervention or scheduled surgery in the subsequent one week * Patients who received digoxin for arrhythmia in the past one week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to cessation of vasopressor use | one week |
Secondary
| Measure | Time frame |
|---|---|
| intensive care unit (ICU) mortality | one month |
| ICU length of stay | one month |
| 28-day survival rate | one month |
Countries
Taiwan
Outcome results
None listed