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A randomized, double-blind, placebo-controlled clinical study of internal and external treatment in the intervention of gastrointestinal dysfunction in sepsis

Application research of internal and external treatment in gastrointestinal dysfunction in sepsis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071405
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal dysfunction in sepsis

Interventions

The intervention group:The treatment is in accordance with the 2021 SSC guideline and the 2012 ESICM AGI guideline. On this basis, both internal and external treatment was given: internal administrati
External Chinese medicine paste (raw rhubarb, etc.) was mixed with mature vinegar and spread flat on a circular tape with a diameter of 6cm. The internal diameter of the medicine paste was 2cm and the
The control group:According to the 2021 SSC and 2012 ESICM guidelines, corresponding treatment is adopted, and on this basis, simulation agent of traditional Chinese medicine decoction substitute for

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. Expected hospital stay and survival time >=7 days in emergency observation ward and ICU; 2. The patients are 18-89 years old with no gender limitation; 3. Gastrointestinal dysfunction is induced by sepsis. The patients should meet the diagnostic criteria of Sepsis 3.0 and 2012 ESICM AGI guideline and TCM syndrome of Spleen Qi deficiency and turbid toxic retention; 4. The patients or their family members are fully informed and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. The patients are failed to be managed with enteral feeding; 2. The patients are complicated with peptic ulcer, gastrointestinal malignancy, pyloric obstruction and other severe gastrointestinal diseases or history of abdominal operations (appendectomy and caesarean section are excluded); 3. The patients are combined with severe diseases of the blood system and immune system; 4. The patients with mental illness, and those who cannot cooperate with the treatment or those with severe anxiety or depression; 5. The patients with skin infections, sores and scars, or allergies to study drugs; 6. The patients who are unable to make bladder pressure measurement (bladder injury or contracture, urethra stenosis or rupture, etc.); 7. The patients use glycerin enema, moxapride, lactulose and other drugs that improve gastrointestinal function; 8. Pregnant, lactating women, or other women who have short-time plan for reproductive requirement; 9. The patients who enroll in other clinical trials during the 3 months prior to the study; 10. The patients who are not considered capable of participating in the study by researchers.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal dysfunction score (2016 Replacing "Lushan conference in 1995" );

Secondary

MeasureTime frame
Gastrointestinal dysfunction score (2008 Beijing Science and Technology Commission standard );AGI grade;Gastrointestinal dysfunction score(GIF standard);Measurement of abdominal pressure;APACHE II;SOFA;NEWS;Death at 28 days;length of hospitalization;I-FABP;T-lymphocyte subsets;IL-13;IFN-?;IL-1ß;WBC;NEUT;PCT;HSCRP;

Countries

China

Contacts

Public ContactYe Huang

Xiyuan Hospital, CACMS

yellow_926@163.com+86 150 1136 7940

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026