Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis

Phase 2Not Yet RecruitingNCT06933238

Dongzhimen Hospital, Beijing70 enrolled

Overview

This study is a single-center, randomized, double-blind, placebo-controlled trial.

The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sepsis Abdominal Gastrointestinal Dysfunction Traditional Chinese Medicine

Interventions

Fuzheng Tongfu Jiedu prescription (FZTFJD)DRUG

Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

PlaceboDRUG

Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III. 2. 50-90 years old, regardless of gender. 3. Sequential Organ Failure Assessment (SOFA) score ≥ 2. 4. Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours. 5. Voluntary participation with signed informed consent. Exclusion Criteria: 1. ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible. 2. Patients with allergies or allergic constitution to the investigational herbal medications. 3. Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight \> 150 kg), trauma, or surgical factors. 4. Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc. 5. History of gastrointestinal surgery. 6. Long-term use of corticosteroids or immunosuppressants. 7. Severe psychiatric disorders or inability to cooperate with trial protocols. 8. Participation in other clinical trials within 30 days. 9. Pregnant or lactating women. 10. Participated in other clinical studies in the past 3 months.

Locations (1)

Ethics Committee of Dongzhimen Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

AGI grade

As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.