Study Stopped
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.
Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMay 23, 2012
May 1, 2012
1.4 years
October 18, 2010
May 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to cessation of vasopressor use
one week
Secondary Outcomes (3)
intensive care unit (ICU) mortality
one month
ICU length of stay
one month
28-day survival rate
one month
Study Arms (2)
Si-Ni-Tang
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical ICU, Changhua Christian Hospital
Changhua, Taiwan, 500, Taiwan
Related Publications (1)
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.
PMID: 21864392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huang-Chi CHEN, M.D.
Changhua Christian Hospital, TAIWAN
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician of the Internal Medicine Department, Changhua Christian Hospital
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 23, 2012
Record last verified: 2012-05