Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Negovsky Reanimatology Research Institute | OTHER_GOV |
| Lomonosov Moscow State University Medical Research and Educational Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-complicated patients | Experimental | patients without any complications after cardiac surgery |
|
| complicated patients | Experimental | patients with any complications, but without gastrointestinal dysfunction after cardiac surgery |
|
| gastrointestinal dysfunction | Experimental | patients with gastrointestinal dysfunction after cardiac surgery |
|
| gastrointestinal dysfunction and MODS | Experimental | patients with gastrointestinal dysfunction and MODS after cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of markers of intestinal dysfunction: | 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 | 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 | During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxim A. Babaev | Contact | +7-916-026-9066 | maxbabaev@mail.ru | |
| Petr V. Ageev | Contact | +7-985-827-0461 | ageev.petia@yandex.ru |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky National Research Centre of Surgery | Moscow | Russia |
For a request, we are ready to consider the possibility
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided