This study is a single-center, randomized, double-blind, placebo-controlled trial.
Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
50-90 years old, regardless of gender.
Sequential Organ Failure Assessment (SOFA) score ≥ 2.
Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
Patients with allergies or allergic constitution to the investigational herbal medications.
Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight > 150 kg), trauma, or surgical factors.
Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
Parallel
Fuzheng Tongfu Jiedu prescription (FZTFJD)
DrugFuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
Placebo
DrugFuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
AGI grade
As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.
Gastrointestinal symptoms score
The gastrointestinal symptoms score will be assessed by GSRS scale. The total score of the GSRS scale ranges from 0 to 78, with higher scores indicating more severe gastrointestinal symptoms.
Abdominal pressure
Abdominal pressure is measured by bladder pressure which is measured by water column method.Higher abdominal pressure levels indicate progressively more severe conditions.
Abdominal circumference
At the end of exhalation and before the beginning of inhalation, the abdominal circumference through the center of the umbilical cord was measured with a soft ruler.
Blood routine
Blood routine test will be determined by blood cell analyzer.White blood cells higher or lower than normal indicate a septic inflammatory state.
Safety index-Blood routine
Blood routine will be detected by test kit.
Safety index-liver function
The indexes related to liver function metabolism, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), direct and indirect bilirubin, albumin, prealbumin and cholinesterase, will be detected by biochemical test
Safety index-Renal function
Renal function test will be detected by test kit.
Safety index-Stool routine
Stool routine will be detected by test kit.
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Dongzhimen Hospital, Beijing
Lead sponsor
Beijing University of Chinese Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
