Petrovsky National Research Centre of Surgery
Moscow, Russia
Location contact
Maxim Babaev, Grand PhD in Medical sciences
CONTACT
Petr Ageev, Junior research assistant
CONTACT
NCT Number: NCT07422246
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
Trial opening soon.
Get Notified18 year–95 year
All sexes
Interventional
Not applicable
Moscow, Russia
Maxim Babaev, Grand PhD in Medical sciences
CONTACT
Petr Ageev, Junior research assistant
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Time frame: 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
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Time frame: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Contact information is provided by the study sponsor or research team.
Maxim A. Babaev
CONTACT
Petr V. Ageev
CONTACT
Petrovsky National Research Centre of Surgery
Other
Acronym: PREDICT-GICS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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