Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure.
- Кому может быть актуально
- Состояния в реестре: Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery, Cardiac Surgery in Adult Patient. Базовые параметры: 18 лет — 95 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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
Подробное описание
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
Вмешательства
- Диагностический тест additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Первичные конечные точки
- Identification of markers of intestinal dysfunction: [Срок оценки: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU]
- The use of pharmacological stimulation of gastrointestinal motility [Срок оценки: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU]
Вторичные конечные точки (6)
- Hospital mortality [Срок оценки: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU]
- Number of days spent in the ICU [Срок оценки: 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 [Срок оценки: 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; [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Patient's refusal to participate in the study;
- HIV infection in the patient;
- Immunosuppressive therapy;
- Oncological disease;
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Россия · 1 центр
- Petrovsky National Research Centre of Surgery — Moscow
Идентификаторы
NCT: NCT07422246 · 17031999