Severe Sepsis
Conditions
Keywords
Severe Sepsis, Sini Decoction, Immune Function, Mortality
Brief summary
The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula documented in Shang Han Lun) in treating severe sepsis.
Interventions
DRUGSi-Ni-Tang
Treatment adheres to the International guidelines for management of severe sepsis and septic shock( 2012) and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015 for both the treatment group and the control group. In addition, 150ml of Si-Ni-Tang will be given by p.o. or by a nasogastric tube once a day for 3 days in the treatment group.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Severe sepsis (according to American college of chest Physicians/ Society of Critical Care Medicine (ACCP/SCCM) criteria) * Informed consent provided by patients or legally authorized representative * Yin syndrome in syndrome differentiation (according to principles of traditional Chinese medicine (TCM) syndrome differentiation)
Exclusion criteria
* Pregnant or nursing female * Subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months * Patients with known or suspicious autoimmune diseases * Patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition * Fasting subjects * Known or suspicious allergy to any ingredient of Si-Ni-Tang * Patients not expected to survive 5 days for various reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality rates | 28 days after enrollment | 28 days all-cause mortality rates after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes | day 0 and 3after enrollment | HLA-DR expression on cluster of differentiation (CD) 14 T lymphocytes measured on day 0 and 3 after enrollment |
| CD 4+/ CD 8+ ratio | day 0 and 3after enrollment | CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment |
| procalcitonin (PCT) | day 0 and 3 after enrollment | PCT measured on day 0 and 3 after enrollment |
| Sequential Organ Failure Assessment (SOFA) score | day 0 and 3 after enrollment | SOFA score measured on day 0 and 3 after enrollment |
Countries
China
Outcome results
None listed