An interventional study of additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure in Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment and Cardiac Surgery, sponsored by Petrovsky National Research Centre of Surgery. Not yet recruiting at 1 site in Russia. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Petrovsky National Research Centre of Surgery · Not applicable, Interventional, and Diagnostic
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
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients without any complications after cardiac surgery
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
patients with any complications, but without gastrointestinal dysfunction after cardiac surgery
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
patients with gastrointestinal dysfunction after cardiac surgery
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
patients with gastrointestinal dysfunction and MODS after cardiac surgery
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
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
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
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
Plan to share: Undecided — For a request, we are ready to consider the possibility
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Petrovsky National Research Centre of Surgery