Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery, Cardiac Surgery in Adult Patient. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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
Interventions
- 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
additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Primary outcome measures
- Identification of markers of intestinal dysfunction: [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]
- The use of pharmacological stimulation of gastrointestinal motility [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]
Secondary outcome measures (6)
- Hospital mortality [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]
- Number of days spent 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]
- Total duration of vasopressor support [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]
- 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; [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]
- Total duration of mechanical lung ventilation [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]
- Surgical interventions on abdominal organs [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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patient's refusal to participate in the study;
- HIV infection in the patient;
- Immunosuppressive therapy;
- Oncological disease;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Russia · 1 center
- Petrovsky National Research Centre of Surgery — Moscow
Identifiers
NCT: NCT07422246 · 17031999