Septic ShockPhase 2NCT01223430
Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients
A Phase 2 study of Septic Shock, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Septic Shock
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Si-Ni-Tang/ Placebo of Si-Ni-Tang
- Keywords
- septic shock, shock reversal, ICU, traditional Chinese medicine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Si-Ni-Tang/ Placebo of Si-Ni-TangDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Si-Ni-Tang | Experimental | Not described Receives: Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang |
| Placebo | Placebo comparator | Not described Receives: Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to cessation of vasopressor use
Measured: one week
Secondary outcomes (3)
intensive care unit (ICU) mortality
Measured: one month
ICU length of stay
Measured: one month
28-day survival rate
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang-Chi Chen, Changhua Christian Hospital
- Investigators
- Huang-Chi CHEN, M.D., Principal investigator, Changhua Christian Hospital, TAIWAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223430
- Sponsor's protocol ID
- CCH IRB 100105
- Status last verified
- May 2012
- First submitted
- 18 Oct 2010
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21864392
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01223430
- Acronym / sponsor ID
- CCH IRB 100105
- Conditions
- Septic Shock
- Keywords
- septic shock, shock reversal, ICU, traditional Chinese medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Si-Ni-Tang | Experimental | Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang |
| Placebo | Placebo comparator | Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Si-Ni-Tang/ Placebo of Si-Ni-TangThe 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. | Drug | Placebo, Si-Ni-Tang |
Primary outcome
time to cessation of vasopressor use
Time frame: one week
3 secondary outcomes
intensive care unit (ICU) mortality
Time frame: one month
ICU length of stay
Time frame: one month
28-day survival rate
Time frame: one month
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Derived from this study: PubMed 21864392Chen 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.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang-Chi CHEN, M.D. principal investigator
Changhua Christian Hospital, TAIWAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Septic Shock, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to cessation of vasopressor use (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.