Sepsis
Conditions
Interventions
Exposed group:TCM herbs/formula internal or external administration
Non-exposed group:Do not received TCM herbs/formula
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1 )Age = 18 Years old (2) Diagnosis meeting the Sepsis 3.0 criteria Sepsis is defined as probable or proven infection with an SOFA score of = 2 points. And "probable or proven infection" has been defined as =3 points within at least one focus (probable or proven infection) based on the Linder-Mellhammar Criteria of Infection (LMCI) or fulfilment of criteria for possible or definite endocarditis according to the modified Duke criteria. (3) One or more organ system failures [Sequential Organ Failure Assessment (SOFA) score for any individual organ system = 2] (4) Admitted to ICU less than 24 h (5) Anticipated ICU stay of more than 72h (6) Informed consent
Exclusion criteria
Exclusion criteria: (1) Abdominal infection sepsis, (defined as "abdominal infection" and/or "gastrointestinal infection" criteria in LMCI = 3 points and SOFA score = 2 points). (2) History of other GI disease: active GI bleeding (BARC subtypes 2-5), intestinal necrosis, ulcerative colitis, radioactive enteritis, inflammatory bowel disease, short bowel, and GI surgery within the past 6 months. (3) Days from sepsis diagnosis to ICU admission =7 days. (4) Acceptance of palliative treatment, such as advanced cancer or any terminal-stage disease. (5) Expected death within 72 hours after enrollment, defined as patients using norepinephrine at a dose of 25mg/min or more under full-fluid resuscitation, with systolic blood pressure <90mmHg and serum pH values <7.0. Determination will be made by the treating physician. (6) Pregnant or lactating women; (7) Cardiac arrest 6 hours before or 1 hours after ICU admission due to difficulty in assessing organ dysfunction and sepsis criteria in the peri-arrest period. (8) Evaluation of AGI not possible for any reason; (9) Participants in other intervention clinical trials (10) For patients admitted multiple times during one hospitalization, only data from the first ICU admission will be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal failure (GF) free days to 14 days after enrollment;Starting time for enteral feeding from ICU admission;Remission and cure rates of AGI on day 7 and day 14;Incidence of feeding intolerance (FI) in the first and second weeks;Delivered dose of enteral feeding on day 7 and day 14;Treatment-duration-ratio (TDR) of TCM;ICU free days to day 14;Hospital free days to day 14;All-cause mortality at day 90 after enrollment;Health-related quality of life (HRQoL) evaluation on day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| New-onset organ failure;New-onset multiple-organ failure (MOF);New-onset persistent organ failure (POF);New receipt of organ support; | — |
Countries
China
Contacts
Public ContactGao Peiyang
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed