The Dynamic Change of Fecal Calprotectin From Day 1 to Day 3 Was Associated With Sepsis-associated Liver Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Occurrence of SALD
研究概览
简要总结
As defined by sepsis 3.0, sepsis is a clinical syndrome caused by disordered host response to serious infection，leading to multiple organ dysfunction1. Sepsis-associated liver dysfunction (SALD) is one of the most frequently complication in sepsis, possessing high morbidity and mortality2.
A close relationship exists between the gut and the liver, and their bidirectional interaction was commonly known as the 'gut-liver' axis3. Systemic inflammation and hypoperfusion play a crucial role in the pathophysiological processes of acute gastrointestinal injury (AGI) in sepsis4. The translocation of bacteria and toxins due to gut barrier injury during AGI can promote the entry of bacteria and their products into the liver through the portal circulation and lymphatic system, leading to the occurrence of SALD. Our previous study found that septic patients with abdominal infections and SALD suffered a higher incidence of AGI when compared with patients without SALD5.
Faecal calprotectin (FC) is a convenient, non-invasive biomarker that has a good correlation with gut inflammation6. The FC concentration is proportional to neutrophil migration to the gut and correlates well with fecal leukocyte excretion7. Study found that FC concentrations were significantly higher in septic patients complicated with AGI than those without, and it can be used as an early indicator for the diagnosis of AGI8. However, the relationship between FC concentration and SALD in septic patient is unclear. We conducted a prospective study to explore the potential association between FC concentration and SALD in septic patients. The dynamic changes in the FC concentration from day 1 to 3 after enrollment were also investigated.
详细描述
Study participants
This was a single-center prospective observational study enrolling consecutive adult patients with sepsis (≥18 years) admitted to Nanjing Drum Tower Hospital between January 2023 to March 2024. The study protocol was approved by the Medical Ethics Committee of local institution (number: 2023-396-03). All patients or their immediate family members provided the informed consent and all study procedures were in line with the Declaration of Helsinki. Exclusion criteria were:
- had diseases originating in the gastrointestinal tract, such as gastrointestinal malignancies and inflammatory bowel disease (IBD);
- complicated by severe chronic liver diseases, such as decompensated cirrhosis and advanced liver cancer;
- hospitalization for primary hepatobiliary disease, such as trauma, hepatitis and hepatic abscess;
- already diagnosed SALD at enrollment;
- were discharged or died within 72 hours after enrollment;
- were pregnant.
All eligible patients were treated according to the sepsis 3.0 guidelines, including: control the source of infection, used antibiotic early and other supportive therapies to maintain organ function. Patients were divided into non-SALD and SALD groups according to SALD whether or not diagnosed during intensive care units (ICU) stay. Eligible patients also be excluded if the following occurs during the study period:
- deviation from the study protocol for any reason;
- have other causes of liver injury, such as drugs and poisons;
- diagnosis of SALD within 72 hours after enrollment;
- patients or their relatives decided to withdraw from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with sepsis
排除标准
- •had diseases originating in the gastrointestinal tract, such as gastrointestinal malignancies and inflammatory bowel disease (IBD);
- •complicated by severe chronic liver diseases, such as decompensated cirrhosis and advanced liver cancer;
- •hospitalization for primary hepatobiliary disease, such as trauma, hepatitis and hepatic abscess;
- •already diagnosed SALD at enrollment;
- •were discharged or died within 72 hours after enrollment;
- •were pregnant.
结局指标
主要结局
Occurrence of SALD
时间窗: 30 days after ICU admission
whether SALD occurs
次要结局
- mortality(30 days after ICU admission)