Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia (AMESI-EST)

May 21, 2026 updated by: Vladislav Mihnovitš, University of Tartu

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tallinn
      • Tallinn, Tallinn, Estonia, 13419
    • Tartu
      • Tartu, Tartu, Estonia, 50406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected acute mesenteric ischemia in the ICU
This is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia. No intervention is done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Baseline
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.

Baseline
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).

Baseline
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.

Baseline
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.

Baseline
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.

Baseline
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.

Baseline
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.

Baseline
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.

Baseline
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.

Baseline
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.

Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
Management of AMI patients
Time Frame: Baseline
Rate of surgical, conservative, endovascular or palliative management
Baseline
30-day survival
Time Frame: 30 days after admission
30-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
30 days after admission
90-day survival
Time Frame: 90 days after admission
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
90 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

September 5, 2026

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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