Sepsis
Conditions
Interventions
Routine treatment :Standard Western medical treatment for sepsis
Routine treatment + NF101 TCM intervention group:Routine treatment + NF101 TCM intervention
Routine treatment + NF102 TCM intervention group:Routine treatment + NF102 TCM intervention
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with sepsis within 48 hours, with the diagnosis of sepsis meeting the Sepsis-3.0 diagnostic criteria, namely confirmed or suspected infection and a SOFA score of =2; (2) SOFA score: 2–13; (3) Aged between 18 and 85 years.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating female patients; (2) Patients who develop stress-related gastrointestinal ulcers, gastrointestinal bleeding, or other conditions requiring fasting during the study; or patients in whom a nasogastric or nasojejunal tube cannot be inserted; (3) Patients with serious underlying diseases, including advanced malignant tumors, hematologic malignancies, acquired immunodeficiency syndrome, or neutropenia; (4) Patients with severe hepatic or renal dysfunction, defined as an individual SOFA subscore of =3 for liver or kidney function; (5) Patients who have undergone organ transplantation within the past 6 months; (6) Patients who have participated in another clinical drug study within the past 1 month; (7) Patients with a history of allergy to traditional Chinese medicine; (8) Patients who refuse to sign the informed consent form; (9) Patients who have used Xuebijing Injection, Shenfu Injection, Shengmai Injection, Shenmai Injection, or other traditional Chinese medicine injections that may affect the efficacy evaluation of this study within 48 hours prior to randomization.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| SOFA change trajectory;Blood coagulation function;Total length of hospital stay;28-day organ support-free days;In-hospital mortality;28-day ICU-free days;Complete blood count;Arterial blood gas analysis;28-day all-cause mortality;ICU mortality;Inflammatory markers; | — |
Primary
| Measure | Time frame |
|---|---|
| SOFA score; | — |
Countries
China
Contacts
Public ContactLi Kong
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed