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NCT Number: NCT07422246

Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients

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

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maxim A. Babaev

CONTACT

[email protected]

+7-916-026-9066

Petr V. Ageev

CONTACT

[email protected]

+7-985-827-0461

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Collaborators

  • Lomonosov Moscow State University Medical Research and Educational Center
  • Negovsky Reanimatology Research Institute

Registry information

Acronym: PREDICT-GICS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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