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Non-Occlusive Mesenteric Ischaemia (NOMI)AMESI-ESTNCT07610356

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

An observational study of Non-Occlusive Mesenteric Ischaemia (NOMI) and Acute Mesenteric Ischemia, run by University of Tartu at 2 sites in Estonia.

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Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observation
How many people
150 participants
Where
2 sitesEstonia
Study dates
6 Jun 2022to 5 Sep 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Estonia2 sites, 2 recruiting
  • North Estonia Medical Centre

    Tallinn, Tallinn, 13419

    Olga Kiss, MD, +372 617 1300, Olga.Kiss@regionaalhaigla.ee

    Recruiting
  • Tartu University Hospital

    Tartu, Tartu, 50406

    Vladislav Mihnovitš, MD, +372 7318111, vladislav.mihnovits@kliinikum.ee

    Recruiting

Other trials in Estonia

About this study

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

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.

Being tested
Observation
Keywords
Acute mesenteric ischemia, non-occlusive mesenteric ischemia, transmural necrosis, predictors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

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

Study groups in NCT07610356
Study groupRoleWhat they receive
Patients with suspected acute mesenteric ischemia in the ICUNot described
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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).

    Measured: Baseline

  4. 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.

    Measured: Baseline

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

    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.

    Measured: Baseline

  6. Predictors of transmural ischemia in NOMI patients - RRT

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

  8. Predictors of transmural ischemia in NOMI patients - CRP

    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.

    Measured: Baseline

  9. Predictors of transmural ischemia in NOMI patients - lactate

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

Secondary outcomes (4)
  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)

    Measured: Baseline

  2. Management of AMI patients

    Rate of surgical, conservative, endovascular or palliative management

    Measured: Baseline

  3. 30-day survival

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

    Measured: 30 days after admission

  4. 90-day survival

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

    Measured: 90 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start6 Jun 2022
  3. Primary completion5 Jun 2026 (estimated)
  4. Study completion5 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610356
Sponsor's protocol ID
AMESI-EST
Acronym
AMESI-EST
Status last verified
May 2026
First submitted
10 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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