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Prognosis and Diagnosis of Acute Gastrointestinal Dysfunction in Cardiac Surgery Patients

ConditionsGastrointestinal DysfunctionCardiac Surgery Intensive Care TreatmentCardiac SurgeryCardiac Surgery in Adult Patient
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorPetrovsky National Research Centre of Surgery

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient's refusal to participate in the study;

HIV infection in the patient;

Immunosuppressive therapy;

Oncological disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: non-complicated patientsExperimental treatment 1 intervention
Group B: complicated patientsExperimental treatment 1 intervention
Group C: gastrointestinal dysfunctionExperimental treatment 1 intervention
Group D: gastrointestinal dysfunction and MODSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
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

Other outcomes

Sponsors and contacts

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Petrovsky National Research Centre of Surgery

Lead sponsor

Negovsky Reanimatology Research Institute

Collaborator

Lomonosov Moscow State University Medical Research and Educational Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: