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

Primary Purpose

Dachengqi Decoction, Probiotic L92

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dachengqi decoction

probiotic L9

Conventional treatment

About this trial

This is an interventional treatment trial for Dachengqi Decoction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Arm Label

Conventional treatment group

Conventional treatment plus L92 group

Conventional treatment plus Dachengqi decoction group

Conventional treatment plus Dachengqi decoction plus L92 group

Arm Description

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

Conventional treatment combined with L92

Conventional treatment combined with Dachengqi Decoction

Conventional treatment combined with L92 and Dachengqi Decoction

Outcomes

Primary Outcome Measures

Incidence of sepsis within 7 days

Secondary Outcome Measures

Full Information

NCT ID

NCT04517045

First Posted

August 14, 2020

Last Updated

August 17, 2020

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04517045

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Anticipated)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dachengqi Decoction, Probiotic L92

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

752 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional treatment group

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Conventional treatment plus L92 group

Arm Type

Experimental

Arm Description

Conventional treatment combined with L92

Arm Title

Conventional treatment plus Dachengqi decoction group

Arm Type

Experimental

Arm Description

Conventional treatment combined with Dachengqi Decoction

Arm Title

Conventional treatment plus Dachengqi decoction plus L92 group

Arm Type

Experimental

Arm Description

Conventional treatment combined with L92 and Dachengqi Decoction

Intervention Type

Drug

Intervention Name(s)

Dachengqi decoction

Other Intervention Name(s)

probiotic L92

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

probiotic L9

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional treatment

Intervention Description

Conventional treatment

Primary Outcome Measure Information:

Title

Incidence of sepsis within 7 days

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

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