The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension

Study Overview
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Brief Summary
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Patients with severe infections, wounds (burns), and severe pancreatitis often have abdominal hypertension (IAH), which is an important objective manifestation of acute gastrointestinal failure in severe patients. Timely diagnosis and effective intervention can improve the treatment rate of patients. In the early stage, we conducted clinical exploration and observational research on the treatment of IAH with Dachengqi Decoction and Lactobacillus in the treatment of critically ill patients including the above diseases, and achieved significant clinical effects. On this basis, it is planned to verify the protective effect of Lactobacillus acidophilus L92, Dachengqi Decoction and the combination of the two on the gastrointestinal mucosal barrier function of patients with IAH and the regulation of the intestinal flora, and analyze the intestinal mucosal barrier The relationship between intestinal flora and the prognosis of IAH patients.

Official Title
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The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension

Conditions
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Dachengqi Decoction, Probiotic L92

Intervention / Treatment
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* Drug: Dachengqi decoction
* Drug: probiotic L9
* Other: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion and exclusion criteria and critically ill patients (acute severe pancreatitis, cervical spinal cord injury) who are 60 years old or older than 18 years old, expected to be mechanically ventilated in the ICU, and hospitalized for more than 48 hours, replaced intra-abdominal pressure monitoring with bladder pressure measurement, and repeated on admission The results of the three measurements are ≥12 mmHg. Exclusion Criteria: Patients who have not signed the informed consent; cannot tolerate intra-abdominal pressure monitoring; pregnant women; patients after bladder surgery; systemic diseases and recent use of related drugs; previous infections, such as history of tuberculosis or PPD positive; previous high History of blood pressure, poor blood pressure control (SBP/DBP>=140mmHg); patients with severe mental illness; long-term use of traditional Chinese medicine, probiotics, gastric mucosal protectors, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc., such as admission The drug was not discontinued within the previous month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional treatment group<br>Control the primary disease, prevent infection, reduce gastrointestinal decompression, and actively maintain organ function. | Other: Conventional treatment<br>* Conventional treatment<br>|
| Experimental: Conventional treatment plus L92 group<br>Conventional treatment combined with L92 | Drug: probiotic L9<br>* L92 2 tablets/time, tid, oral or nasal feeding<br>Other: Conventional treatment<br>* Conventional treatment<br>|
| Experimental: Conventional treatment plus Dachengqi decoction group<br>Conventional treatment combined with Dachengqi Decoction | Drug: Dachengqi decoction<br>* Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial<br>* Other names: probiotic L92;Other: Conventional treatment<br>* Conventional treatment<br>|
| Experimental: Conventional treatment plus Dachengqi decoction plus L92 group<br>Conventional treatment combined with L92 and Dachengqi Decoction | Drug: Dachengqi decoction<br>* Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial<br>* Other names: probiotic L92;Drug: probiotic L9<br>* L92 2 tablets/time, tid, oral or nasal feeding<br>Other: Conventional treatment<br>* Conventional treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sepsis within 7 days |  | six months |