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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01223430
Recruitment Status : Terminated (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.)
First Posted : October 19, 2010
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Huang-Chi Chen, Changhua Christian Hospital

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Si-Ni-Tang Drug: Si-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.

Placebo Comparator: Placebo Drug: Si-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.




Primary Outcome Measures :
  1. time to cessation of vasopressor use [ Time Frame: one week ]

Secondary Outcome Measures :
  1. intensive care unit (ICU) mortality [ Time Frame: one month ]
  2. ICU length of stay [ Time Frame: one month ]
  3. 28-day survival rate [ Time Frame: one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223430


Locations
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Taiwan
Medical ICU, Changhua Christian Hospital
Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
Investigators
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Principal Investigator: Huang-Chi CHEN, M.D. Changhua Christian Hospital, TAIWAN
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Huang-Chi Chen, Attending Physician of the Internal Medicine Department, Changhua Christian Hospital, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01223430    
Other Study ID Numbers: CCH IRB 100105
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Huang-Chi Chen, Changhua Christian Hospital:
septic shock
shock reversal
ICU
traditional Chinese medicine
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation