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

NCT04517045 | Unknown Phase 2

• 1 other identifier: XH-20-017
• Study Type: interventional
• Target: 752
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dachengqi Decoction; Probiotic L92

Outcome Measures

Primary Outcomes (1)

• Incidence of sepsis within 7 days

  six months

Study Arms (4)

Conventional treatment group

SHAM COMPARATOR

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

Other: Conventional treatment

Conventional treatment plus L92 group

EXPERIMENTAL

Conventional treatment combined with L92

Drug: probiotic L9; Other: Conventional treatment

Conventional treatment plus Dachengqi decoction group

EXPERIMENTAL

Conventional treatment combined with Dachengqi Decoction

Drug: Dachengqi decoction; Other: Conventional treatment

Conventional treatment plus Dachengqi decoction plus L92 group

EXPERIMENTAL

Conventional treatment combined with L92 and Dachengqi Decoction

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

Interventions

Dachengqi decoction DRUG

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

Also known as: probiotic L92

Conventional treatment plus Dachengqi decoction group; Conventional treatment plus Dachengqi decoction plus L92 group

probiotic L9 DRUG

L92 2 tablets/time, tid, oral or nasal feeding

Conventional treatment plus Dachengqi decoction plus L92 group; Conventional treatment plus L92 group

Conventional treatment OTHER

Conventional treatment

Conventional treatment group; Conventional treatment plus Dachengqi decoction group; Conventional treatment plus Dachengqi decoction plus L92 group; Conventional treatment plus L92 group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Interventions

dachengqi decoction

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: October 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: August 18, 2020

Record last verified: 2020-08