Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients

NCT07422246 | Not Yet Recruiting

• 1 other identifier: 17031999
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (4)

non-complicated patients

EXPERIMENTAL

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

complicated patients

EXPERIMENTAL

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

gastrointestinal dysfunction

EXPERIMENTAL

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

gastrointestinal dysfunction and MODS

EXPERIMENTAL

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

Interventions

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

complicated patients; gastrointestinal dysfunction; gastrointestinal dysfunction and MODS; non-complicated patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient's refusal to participate in the study;
• HIV infection in the patient;
• Immunosuppressive therapy;
• Oncological disease;

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead
• Negovsky Reanimatology Research Institute: collaborator
• Lomonosov Moscow State University Medical Research and Educational Center: collaborator

Study Sites (1)

Petrovsky National Research Centre of Surgery

Moscow, Russia

Location

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Maxim A. Babaev

CONTACT

+7-916-026-9066; maxbabaev@mail.ru

Petr V. Ageev

CONTACT

+7-985-827-0461; ageev.petia@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

RU (1)