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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Dachengqi Decoction; Probiotic L92

Treatments: Drug: Dachengqi decoction; Other: Conventional treatment; Drug: probiotic L9

Study type: Interventional

Funder types: Other

Identifiers

NCT04517045

XH-20-017

Details and patient eligibility

About

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.

Enrollment: 752 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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752 participants in 4 patient groups

Conventional treatment group

Sham Comparator group

Description:

Control the primary disease, prevent infection, reduce gastrointestinal decompression, and actively maintain organ function.

Treatment:

Other: Conventional treatment

Conventional treatment plus L92 group

Experimental group

Description:

Conventional treatment combined with L92

Treatment:

Other: Conventional treatment

Drug: probiotic L9

Conventional treatment plus Dachengqi decoction group

Experimental group

Description:

Conventional treatment combined with Dachengqi Decoction

Treatment:

Drug: Dachengqi decoction

Other: Conventional treatment

Conventional treatment plus Dachengqi decoction plus L92 group

Experimental group

Description:

Conventional treatment combined with L92 and Dachengqi Decoction

Treatment:

Drug: Dachengqi decoction

Other: Conventional treatment

Drug: probiotic L9