Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Tartu
About this trial
Acute mesenteric ischemia (AMI) is a rare but life-threatening condition associated with high mortality and major diagnostic challenges due to nonspecific clinical presentation and limited reliable biomarkers. Critically ill patients in the intensive care unit (ICU) are at particularly high risk of non-occlusive mesenteric ischemia (NOMI), a subtype of AMI characterized by impaired mesenteric perfusion without large-vessel occlusion. Despite advances in imaging, the diagnosis of NOMI remains difficult, and data specifically focusing on ICU patients with suspected AMI are limited.
This prospective observational multicenter study aims to identify independent predictors of transmural NOMI among ICU patients with suspected AMI. In addition, the study will describe demographics, comorbidities, clinical presentation, laboratory findings, diagnostic imaging, management strategies, and outcomes among ICU patients with NOMI, other forms of AMI, and patients with suspected but unconfirmed AMI. Consecutive adult ICU patients in whom clinical suspicion of AMI arises during ICU stay will be included across Estonian regional hospitals. The study is a local continuation of the international AMESI study, with a specific focus on critically ill ICU patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients who develop acute mesenteric ischemia outside of the intensive care unit,
Confirmed strangulating bowel obstruction,
Individuals younger than 18 years,
Chronic mesenteric ischemia without an acute event.
Trial population
All adult patients who develop suspicion of acute mesenteric ischemia during their ICU stay will be included in the study. The study will take place in the ICUs of the two largest hospitals in Estonia: Tartu University Hospital and North Estonian Medical Centre.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation
Other interventionThis is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia. No intervention is done.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients with suspected acute mesenteric ischemia in the ICU1 intervention
Trial outcomes
Primary outcomes
1
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia. Variable: \- age-adjusted Charlson comorbidity index (Range 0 - 37 points). A higher score indicates a higher chance of 10-year mortality.
Time frame
Baseline2
Predictors of transmural necrosis in NOMI patients - SOFA score
To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia. Variable: \- Sequential Organ Failure Assessment (SOFA) score (Range 0 - 24 points). Higher scores indicate more severe organ dysfunction.
Time frame
Baseline3
Predictors of transmural necrosis in NOMI patients - GRV
To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia. Variable: \- Gastric residual volume (GRV) greater than 500 ml at any point within the 48 hours prior to the suspicion of acute mesenteric ischemia (AMI) will be recorded as a Yes or No variable. A high GRV indicates feeding intolerance, which may suggest non-occlusive mesenteric ischemia. This is a retrospective variable. After a patient is enrolled in the study, the patient's ICU datasheet will be retrospectively analyzed to determine if there was a GRV above 500 ml. If such an event occurred within the 48 hours prior to inclusion, the variable will be considered positive (Yes); if not, it will be considered negative (No).
Time frame
Baseline4
Predictors of transmural ischemia in NOMI patients - bloody stool.
To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia. Variable: \- Presence of bloody stool. Yes or No variable. Bloody stool might indicate gastrointestinal ischemia.
Time frame
BaselineSecondary outcomes
1
CT findings in patients with suspected AMI
Computed tomography variables in patients with suspicion of acute mesenteric ischemia will be analysed. Variables: * Presence of bowel dilatation (Yes or No variable) * Pathological bowel wall enhancement (categorization: absence or decrease enhancement; normal enhancement; increased enhancement) * Presence of pneumatosis intestinalis (Yes or No variable) * Presence of gas in the mesenteric or portal venous system (Yes or No variable) * Thickening of the bowel wall (Yes or No variable) (small bowel \> 3 mm, large bowel \> 3 mm if distended or \> 5 mm if not distended) * Thinning of the bowel wall (Yes or No variable)
Time frame
Baseline2
Management of AMI patients
Rate of surgical, conservative, endovascular or palliative management
Time frame
Baseline3
30-day survival
30-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
Time frame
30 days after admission4
90-day survival
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
Time frame
90 days after admissionSponsors and contacts
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Source ClinicalTrials.gov