sepsis-induced gastrointestinal dysfunction
Conditions
Interventions
Control Group:Conventional western medicine treatment + Retention enema with soapy water (once a day and 30min each time).
Experimental Group:Conventional western medicine treatment + Retention enema with Tongfu Mixture (once a day and 30min each time.)
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: ? Patients admitted to ICU of Dongzmen Hospital Beijing University of Chinese Medicine from October 2024 to December 2026. ? In accordance with the diagnosis of septic gastrointestinal dysfunction and the syndrome differentiation was Fuqi obstruction and AGI grade: grade i-?; ? Age 18= age < 90 years old regardless of gender; ?SOFA score: 2-12 points; ? Within 24 hours of the diagnosis of septic gastrointestinal dysfunction; ? Voluntarily participated in this trial and signed informed consent
Exclusion criteria
Exclusion criteria: ? Daily frequency of watery stools >3 times with total volume exceeding 1000ml. ? Inability to evaluate gastrointestinal function changes due to ICU length of stay =7 days (e.g. death discharge or transfer out of ICU). ? Inability to measure intra-abdominal pressure and abdominal circumference due to excessive body weight (>150kg) trauma or surgery. ? Severe organic diseases (e.g. end-stage hematologic malignancies decompensated liver cirrhosis HIV) with imminent risk of life-threatening complications. ? Patients who underwent gastrointestinal surgery. ? Long-term use of corticosteroids immunosuppressants or similar medications. ? Diagnosed with severe psychiatric disorders or inability to comply with trial protocols. ? Participation in other clinical trials within 30 days prior to enrollment. ? Pregnant or lactating women. ? Allergy to the herbal medicines used in this project or history of allergic predisposition. ? Inability to cooperate with enema therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM symptom score;AGI Grading Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of sepsis: SOFA score and APACHE? score;Abdominal circumference;28-day mortality.;Length of ICU stay;Related indexes of intestinal peristalsis: 1) serum gastrin, motilin, cholecystokinin levels; 2) Gastric emptying time (GET), antral contraction frequency (ACF), antral contraction amplitude (ACA), antral motility index (MI), small intestine diameter, colon diameter, peristalsis, small intestine mucosal thickness and colon mucosal thickness were evaluated by ultrasound.;Inflammatory markers: Whole blood WBC, NE%, CRP, PCT and serum TNF-a, IL-6, IL-10 and NF-?B levels;Abdominal pressure;Bowel sounds;Improvement of TCM symptoms: Fuqi obstruction;;? Intestinal flora detection: metagene detection;Intestinal barrier function related indicators: serum diamine oxidase (DAO), D-lactic acid levels(D-LA), intestinal type Fatty acid binding protein (I-FABP), citrulline (CIT); | — |
Countries
China
Contacts
Public ContactNan Guo
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed