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The IRB considered our trial risky. Although there were debates between investigators and IRB, we terminated our trial in accordance with the suggestion of IRB.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Si-Ni-Tang | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Si-Ni-Tang/ Placebo of Si-Ni-Tang | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| time to cessation of vasopressor use | one week |
| Measure | Description | Time Frame |
|---|---|---|
| intensive care unit (ICU) mortality | one month | |
| ICU length of stay | one month | |
| 28-day survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huang-Chi CHEN, M.D. | Changhua Christian Hospital, TAIWAN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical ICU, Changhua Christian Hospital | Changhua | Taiwan | 500 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21864392 | Derived | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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|
| one month |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |