The Clinical Effect and Mechanism of Fuzheng Tongfu Jiedu Prescription Regulating Cell Pyrodeath in the Treatment of Gastrointestinal Dysfunction in Sepsis Based on mtDNA/NLRP3/Caspase-1/GSDMD Signaling Pathway
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- AGI grade
研究概览
简要总结
This study is a single-center, randomized, double-blind, placebo-controlled trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
- •50-90 years old, regardless of gender.
- •Sequential Organ Failure Assessment (SOFA) score ≥
- •Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
- •Voluntary participation with signed informed consent.
排除标准
- •ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
- •Patients with allergies or allergic constitution to the investigational herbal medications.
- •Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight > 150 kg), trauma, or surgical factors.
- •Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
- •History of gastrointestinal surgery.
- •Long-term use of corticosteroids or immunosuppressants.
- •Severe psychiatric disorders or inability to cooperate with trial protocols.
- •Participation in other clinical trials within 30 days.
- •Pregnant or lactating women.
- •Participated in other clinical studies in the past 3 months.
研究组 & 干预措施
Fuzheng Tongfu Jiedu prescription (FZTFJD)
Basic treatment + Fuzheng Tongfu Jiedu prescription
干预措施: Fuzheng Tongfu Jiedu prescription (FZTFJD) (Drug)
Placebo
Basic treatment + Fuzheng Tongfu Jiedu prescription placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AGI grade
时间窗: Day0, Day3,Day7,Day14
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.
次要结局
- Gastrointestinal symptoms score(Day0, Day3,Day7,Day14)
- Abdominal pressure(Day0, Day3,Day7,Day14)
- Abdominal circumference(Day0, Day3,Day7,Day14)
- Blood routine(Day0, Day3,Day7,Day14)
- CRP(Day0, Day3,Day7,Day14)
- PCT(Day0, Day3,Day7,Day14)
- Immune index-T cell functional subsets(Day0,Day7)
- Immune index-lymphocyte subsets(Day0, Day7)
- Intestinal barrier function-diamine oxidase（DAO）(Day0, Day7)
- Intestinal barrier function-D-lactic acid level(Day0, Day7)
- Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP)(Day0、 Day7)
- Intestinal barrier function-Citrulline (CIT)(Day0、 Day7)
- Severity of sepsis-SOFA score(Day0、 Day3、Day7、Day14)
- Severity of sepsis-APACHE Ⅱ(Day0、 Day3、Day7、Day14)
- Length of ICU stay(Day28)
- 28-day mortality(Day28)
研究者
ljhly05
Doctor
Dongzhimen Hospital, Beijing