Clinical trial NCT01223430: Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients
Official title: Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Septic Shock
Keywords: septic shock
shock reversal
ICU
traditional Chinese medicine
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to cessation of vasopressor use
timeFrame: one week
Secondary outcomes:
measure: intensive care unit (ICU) mortality
timeFrame: one month
measure: ICU length of stay
timeFrame: one month
measure: 28-day survival rate
timeFrame: one month
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Medical ICU, Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital, TAIWAN
name: Huang-Chi CHEN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen HC, Chen WC, Lin KH, Chen YH, Lo LC, Lee TC, Hsia TC, Wang CH, Wu SH, Hsu HW, Chang YJ, Huang YC, Ku TH, Horng MH. Simultaneous use of traditional Chinese medicine (si-ni-tang) to treat septic shock patients: study protocol for a randomized controlled trial. Trials. 2011 Aug 24;12:199. doi: 10.1186/1745-6215-12-199.