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.
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
- Conditions the study is for
- Non-Occlusive Mesenteric Ischaemia (NOMI), Acute Mesenteric Ischemia
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Patients with suspected acute mesenteric ischemia in the ICU | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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
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
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)
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
Management of AMI patients
Rate of surgical, conservative, endovascular or palliative management
Measured: Baseline
30-day survival
30-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
Measured: 30 days after admission
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.
- First posted28 May 2026
- Study start6 Jun 2022
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Occlusive Mesenteric Ischaemia (NOMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladislav Mihnovitš, University of Tartu
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