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

Changhua Christian Medical Foundation

Status and phase: Terminated; Phase 2

Conditions: Septic Shock

Treatments: Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang

Study type: Interventional

Funder types: Other

Identifiers

NCT01223430

CCH IRB 100105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Si-Ni-Tang

Experimental group

Treatment:

Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang

Placebo

Placebo Comparator group

Treatment:

Drug: Si-Ni-Tang/ Placebo of Si-Ni-Tang