Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients (PREDICT-GICS)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Gastrointestinal Dysfunction; Cardiac Surgery Intensive Care Treatment; Cardiac Surgery in Adult Patient
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxim A. Babaev; Phone Number: +7-916-026-9066; Email: maxbabaev@mail.ru
• Study Contact Backup: Name: Petr V. Ageev; Phone Number: +7-985-827-0461; Email: ageev.petia@yandex.ru

Study Locations

• Russia
  • Moscow, Russia
    • Petrovsky National Research Centre of Surgery
    • Contact: Maxim Babaev, Grand PhD in Medical sciences; Phone Number: +7-916-026-9066; Email: maxbabaev@mail.ru
    • Contact: Petr Ageev, Junior research assistant; Phone Number: +7-985-827-0461; Email: ageev.petia@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-complicated patients; 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; additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Experimental: complicated patients; 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; additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Experimental: gastrointestinal dysfunction; 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; additional blood testing for specific and non-specific markers of intestinal dysfunction, ultrasound examination of abdominal organs and measurement of intra-abdominal pressure
Experimental: gastrointestinal dysfunction and MODS; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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		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

Outcome Measure	Time Frame
Hospital mortality	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	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	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;	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	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	During the first 24h after surgery for all patients. On the third, sixth and ninth day, if the patient stay in the ICU

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Collaborators: Negovsky Reanimatology Research Institute; Lomonosov Moscow State University Medical Research and Educational Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; gastrointestinal complications; gastrointestinal dysfunction; intestinal failure; intestinal dysfunction; multiorgan dysfunction syndrome; gastrointestinal failure
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Failure
• Other Study ID Numbers: 17031999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: For a request, we are ready to consider the possibility

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No