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

21 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Estland
    • Tallinn
      • Tallinn, Tallinn, Estland, 13419
    • Tartu
      • Tartu, Tartu, Estland, 50406

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients with suspected acute mesenteric ischemia in the ICU
Ander: Observation
This is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia. No intervention is done.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CT findings in patients with suspected AMI
Tijdsspanne: 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
Tijdsspanne: Baseline
Rate of surgical, conservative, endovascular or palliative management
Baseline
30-day survival
Tijdsspanne: 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
Tijdsspanne: 90 days after admission
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
90 days after admission

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Tartu

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 juni 2022

Primaire voltooiing (Geschat)

5 juni 2026

Studie voltooiing (Geschat)

5 september 2026

Studieregistratiedata

Eerst ingediend

10 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AMESI-EST

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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