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

Phase 2

Terminated

• Conditions: Septic Shock
• Interventions: Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang

• Registration Number: NCT01223430
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Si-Ni-Tang/ Placebo of Si-Ni-Tang	-
Si-Ni-Tang	Si-Ni-Tang/ Placebo of Si-Ni-Tang	-

Primary Outcome Measures

Name	Time	Method
time to cessation of vasopressor use	one week

Secondary Outcome Measures

Name	Time	Method
intensive care unit (ICU) mortality	one month
ICU length of stay	one month
28-day survival rate	one month

Trial Locations

Locations (1)

Medical ICU, Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan