Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Si-Ni-Tang<br> | Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to cessation of vasopressor use |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensive care unit (ICU) mortality |  | one month | 
| ICU length of stay |  | one month | 
| 28-day survival rate |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, shock reversal, ICU, traditional Chinese medicine