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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01223430
• Other study ID #: CCH IRB 100105
• Status: Terminated
• Phase: Phase 2
• First received: October 18, 2010
• Last updated: May 21, 2012
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: May 2012
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Medical ICU, Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to cessation of vasopressor use		one week	No
Secondary	intensive care unit (ICU) mortality		one month	No
Secondary	ICU length of stay		one month	No
Secondary	28-day survival rate		one month	No