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Real-world study on the clinical efficacy of traditional Chinese medicine in treating sepsis-induced AGI

Real-world study on the clinical efficacy of traditional Chinese medicine in treating sepsis-induced AGI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000221
Enrollment
Unknown
Registered
2025-02-08
Start date
2024-10-30
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-associated AGI

Interventions

Treatment group:Basic Western medicine treatment+ Traditional Chinese medicine treatment

Sponsors

Henan Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age ranges from 18 to 85 years old; 2Sepsis-induced AGI cases need to meet the diagnosis of both Sepsis and AGI; 2.1 Diagnostic criteria for sepsis Refer to the diagnostic criteria for sepsis in the "Chinese Guidelines for Emergency Treatment of Sepsis/Sepsis Shock 2018" (1) Infection or suspected infection Infection indicators: Confirmed or highly suspected infection should possess the following clinical features: 1) Fever (deep body temperature > 38.3°C) or hypothermia (deep body temperature 90 beats per minute or > 2 standard deviations of the normal heart rate for different ages; 3) Tachypnea respiratory rate > 30 breaths per minute. Infection can be determined if two or more of the above three items are met. (2) Change in SOFA score = 2 points Patients with infection or suspected infected sepsis can be diagnosed when the Sepsis-related Organ Failure Assessment (SOFA) score increases by = 2 points compared to the baseline. 2.2 Diagnostic criteria for acute gastrointestinal injury (AGI) Refer to the definition and grading criteria for acute gastrointestinal injury (AGI) formulated by the European Society of Intensive Care Medicine (ESICM) in 2012 (1) AGI grade I: It refers to partial impairment of gastrointestinal function characterized by being temporary and self-limiting. (2) AGI grade II: The digestive and absorptive functions of the gastrointestinal tract cannot meet the body's nutritional and fluid requirements. (3) AGI grade III: Gastrointestinal function is lost and remains ineffective after taking intervention measures (such as erythromycin postpyloric intubation etc.). (4) AGI grade IV: AGI progresses to a life-threatening factor accompanied by multiple organ failure and shock. 3. Acute episode duration is within 3 days.

Exclusion criteria

Exclusion criteria: (1) Patients with severe allergic constitution; (2) Patients with concurrent pregnancy; (3) ICU stay <7 days; (4) Patients with definite immunodeficiency diseases or other definite immunosuppressive conditions.

Design outcomes

Primary

MeasureTime frame
The effective rate of clinical treatment in traditional Chinese medicine;Clinical symptom relief rate and days;

Secondary

MeasureTime frame
Total treatment cost;Procalcitonin;28-day mortality;Platelet;SOFA and APACHE II scores before and after treatment;D-Dimer;White blood cell count;

Countries

China

Contacts

Public ContactLihui Wang

Henan Provincial Traditional Chinese Medicine Hospital

davidwlh@163.com15038276390

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026