Gastrointestinal DysfunctionPREDICT-GICSNCT07422246
Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
A study testing additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure in people with Gastrointestinal Dysfunction and Cardiac Surgery Intensive Care Treatment, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery
- What is being tested?
- additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient's refusal to participate in the study;
- HIV infection in the patient;
- Immunosuppressive therapy;
- Oncological disease;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Petrovsky National Research Centre of Surgery
Moscow
Maxim Babaev, Grand PhD in Medical sciences, +7-916-026-9066, maxbabaev@mail.ru
Petr Ageev, Junior research assistant, +7-985-827-0461, ageev.petia@yandex.ru
About this study
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
Read the 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
- Conditions
- Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery, Cardiac Surgery in Adult Patient
- Being tested
- additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
- Keywords
- cardiac surgery, intestinal dysfunction, gastrointestinal dysfunction, gastrointestinal complications, multiorgan dysfunction syndrome, intestinal failure, gastrointestinal failure
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressureDiagnostic test
additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
| Study group | Role | What they receive |
|---|---|---|
| non-complicated patients | Experimental | patients without any complications after cardiac surgery Receives: 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 |
| complicated patients | Experimental | patients with any complications, but without gastrointestinal dysfunction after cardiac surgery Receives: 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 |
| gastrointestinal dysfunction | Experimental | patients with gastrointestinal dysfunction after cardiac surgery Receives: 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 |
| gastrointestinal dysfunction and MODS | Experimental | patients with gastrointestinal dysfunction and MODS after cardiac surgery Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Secondary outcomes (6)
Hospital mortality
Measured: 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
Measured: 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
Measured: 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;
Measured: 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
Measured: 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
Measured: During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Mar 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Negovsky Reanimatology Research Institute, Lomonosov Moscow State University Medical Research and Educational Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422246
- Sponsor's protocol ID
- 17031999
- Acronym
- PREDICT-GICS
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For a request, we are ready to consider the possibility
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07422246
- Acronym / sponsor ID
- PREDICT-GICS / 17031999
- Conditions
- Gastrointestinal Dysfunction, Cardiac Surgery Intensive Care Treatment, Cardiac Surgery, Cardiac Surgery in Adult Patient
- Keywords
- cardiac surgery, intestinal dysfunction, gastrointestinal dysfunction, gastrointestinal complications, multiorgan dysfunction syndrome, intestinal failure, gastrointestinal failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Collaborators
- Negovsky Reanimatology Research Institute, Lomonosov Moscow State University Medical Research and Educational Center
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-complicated patients | Experimental | Diagnostic Test: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressurepatients without any complications after cardiac surgery |
| complicated patients | Experimental | Diagnostic Test: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressurepatients with any complications, but without gastrointestinal dysfunction after cardiac surgery |
| gastrointestinal dysfunction | Experimental | Diagnostic Test: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressurepatients with gastrointestinal dysfunction after cardiac surgery |
| gastrointestinal dysfunction and MODS | Experimental | Diagnostic Test: additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressurepatients with gastrointestinal dysfunction and MODS after cardiac surgery |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patient's refusal to participate in the study;
- HIV infection in the patient;
- Immunosuppressive therapy;
- Oncological disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressureadditional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure | Diagnostic test | complicated patients, gastrointestinal dysfunction, gastrointestinal dysfunction and MODS, non-complicated patients |
Primary outcome
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
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
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided. For a request, we are ready to consider the possibility
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure in people with Gastrointestinal Dysfunction and Cardiac Surgery Intensive Care Treatment, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxim A. Babaev (+7-916-026-9066, maxbabaev@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.