Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of markers of intestinal dysfunction:
研究概览
简要总结
The purpose of this prospective observational clinical cohort study is to develop a scientifically based approach to the prediction and early diagnosis of intestinal dysfunction in cardiac surgery patients.
The main questions that the study should answer:
What are the main risk factors for the development of intestinal dysfunction? What specific and non-specific biomarkers can predict the development of intestinal dysfunction? The study participants will be monitored from the moment of hospitalization until the end of their stay in a medical facility
详细描述
Despite the low incidence rate from 1% to 2.5%, acute intestinal dysfunction is the cause or key link in the development and progression of multiorgan dysfunction and sepsis, which, in turn, contributes to an increase in the length of hospital stay, the need for additional diagnostic and/or therapeutic interventions, including surgical, and is also associated with high mortality (Mishra et al. 2021, Shvartsova et al. 2024).
Acute intestinal dysfunction is understood as combined disorders of the motor, secretory, digesting, absorption and barrier functions of the intestine, leading to the upward contamination of conditionally pathogenic microbiota from the distal to the proximal sections, the development of uncontrolled translocation of microbes and their metabolites into the blood, which leads to the shutdown of the small intestine from the interstitial metabolism, creates the prerequisites for irreversible disorders of the main indicators homeostasis (Machulina I.A., Shestopalov A.E., Evdokimov E.A. 2020, Popova T.S., Tamazashvili T.S., Shestopalova A.E. 1991).
A feature of acute intestinal dysfunction is an extremely nonspecific clinical and laboratory findings and the absence of widely available organ-specific markers. These reasons do not allow the development of complications to be detected early enough. Currently, most of the literature data is devoted mainly to the statistical description of the incidence, type of abdominal complications and outcome in patients with cardiac surgery. Acute intestinal dysfunction is not included in the list of organ systems tested to determine the severity of organ dysfunctions.
SOFA due to the lack of a reliable diagnostic tool. Measurement data of intra-abdominal pressure, peristalsis activity, and volume of gastric contents in gastrostasis are most often used to monitor intestinal dysfunction.
.The present study aims to explore the possibilities of verification of intestinal dysfunction by combining test results on specific and non-specific scales and dynamics of the level of molecular biomarkers; and to offer a tool for forecasting and early diagnosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery on the heart and main vessels with a high risk of developing gastrointestinal dysfunction (according to literature data and our own retrospective study);
- •Patient's consent to participate in the study
排除标准
- •Patient's refusal to participate in the study;
- •HIV infection in the patient;
- •Immunosuppressive therapy;
- •Oncological disease;
研究组 & 干预措施
non-complicated patients
patients without any complications after cardiac surgery
干预措施: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure (Diagnostic Test)
complicated patients
patients with any complications, but without gastrointestinal dysfunction after cardiac surgery
干预措施: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure (Diagnostic Test)
gastrointestinal dysfunction
patients with gastrointestinal dysfunction after cardiac surgery
干预措施: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure (Diagnostic Test)
gastrointestinal dysfunction and MODS
patients with gastrointestinal dysfunction and MODS after cardiac surgery
干预措施: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure (Diagnostic Test)
结局指标
主要结局
Identification of markers of intestinal dysfunction:
时间窗: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Intra-abdominal hypertension of 2 or more degrees and/or gastrostasis (stomach volume \>1.5ml / kg body weight measured no earlier than 4 hours after the last meal); Abdominal compartment syndrome
The use of pharmacological stimulation of gastrointestinal motility
时间窗: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
次要结局
- Number of days spent in the ICU(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)
- Total duration of vasopressor support(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)
- The dynamics of the severity of the course on the scale of sequential organ dysfunction (SOFA/SOFA-2) in patients with intestinal dysfunction in the framework of multiorgan dysfunction;(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)
- Total duration of mechanical lung ventilation(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)
- Surgical interventions on abdominal organs(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)
- Hospital mortality(During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU)