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NCT Number: NCT07610356

Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia

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.

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Key information

Conditions

Non-Occlusive Mesenteric Ischaemia (NOMI) Acute Mesenteric Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonia Medical Centre, Tallinn, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult ICU patients in whom clinical suspicion of acute mesenteric ischemia is raised during their ICU stay.

Exclusion criteria

  • 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.

Treatment and study plan

observation

Other

This is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia. No intervention is done.

Primary outcomes

  1. Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index

    Time frame: Baseline

    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.

  2. Predictors of transmural necrosis in NOMI patients - SOFA score

    Time frame: Baseline

    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.

  3. Predictors of transmural necrosis in NOMI patients - GRV

    Time frame: Baseline

    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).

  4. Predictors of transmural ischemia in NOMI patients - bloody stool.

    Time frame: Baseline

    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.

  5. Predictors of transmural ischemia in NOMI patients - cardiac arrest.

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Cardiac arrest. Yes or No variable. If the patient was hospitalised due to cardiac arrest, then Yes, if not, then No. Cardiac arrest is a risk factor for developing NOMI.

  6. Predictors of transmural ischemia in NOMI patients - RRT

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Need for renal replacement therapy (RRT) prior to suspicion of AMI. The variable is a Yes or No question. Once a patient is enrolled in the study, a retrospective analysis of their data sheet will be conducted to determine if the patient received renal replacement therapy (RRT) during their hospital stay prior to their inclusion in the study. RRT is a risk factor for developing non-occlusive mesenteric ischemia.

  7. Predictors of transmural ischemia in NOMI patients - WBC.

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Highest White blood cell (WBC) levels within 72 hours prior to suspicion of acute mesenteric ischemia. Units: 10*12 /L. The highest WBC value within the 72 hours prior to suspicion of AMI will be recorded. Higher values indicate a more severe inflammatory response.

  8. Predictors of transmural ischemia in NOMI patients - CRP

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • C-reactive protein (CRP). Units: mg/L. The highest CRP value within the 72 hours prior to suspicion of AMI will be recorded. Higher values indicate a severe inflammatory response.

  9. Predictors of transmural ischemia in NOMI patients - lactate

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Highest lactate value. Units: mmol/L. The highest lactate value within the 12 hours prior to suspicion of AMI will be recorded. Higher values indicate worse tissue perfusion.

  10. Predictors of transmural ischemia in NOMI patients - pneumatosis intestinalis

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Pneumatosis intestinalis. Yes or No variable.In patients suspected of acute mesenteric ischemia, the presence of pneumatosis intestinalis observed on computed tomography will be documented. The presence of pneumatosis intestinalis can indicate mesenteric ischemia.

  11. Predictors of transmural ischemia in NOMI patients - bowel wall enhancement

    Time frame: Baseline

    To identify independent predictors of transmural necrosis in patients with non-occlusive mesenteric ischemia.

    Variable:

    • Decreased bowel wall enhancement on the computed tomography. Yes or No variable. In patients suspected of acute mesenteric ischemia, the decrease in bowel wall enhancement observed on computed tomography will be documented. The decrease in bowel wall enhancement on CT can indicate mesenteric ischemia.

Secondary outcomes

  1. CT findings in patients with suspected AMI

    Time frame: Baseline

    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)

  2. Management of AMI patients

    Time frame: Baseline

    Rate of surgical, conservative, endovascular or palliative management

  3. 30-day survival

    Time frame: 30 days after admission

    30-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU

  4. 90-day survival

    Time frame: 90 days after admission

    90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

Mesenteric Ischemia in the ICU: A Prospective Observational Study Across Estonian Regional Hospitals

Acronym: AMESI-EST

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

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

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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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