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

21 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

150

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Estonie
    • Tallinn
      • Tallinn, Tallinn, Estonie, 13419
        • Recrutement
        • North Estonia Medical Centre
        • Contact:
    • Tartu
      • Tartu, Tartu, Estonie, 50406

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with suspected acute mesenteric ischemia in the ICU
Autre: Observation
This is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia. No intervention is done.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
CT findings in patients with suspected AMI
Délai: 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
Délai: Baseline
Rate of surgical, conservative, endovascular or palliative management
Baseline
30-day survival
Délai: 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
Délai: 90 days after admission
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
90 days after admission

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Tartu

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 juin 2022

Achèvement primaire (Estimé)

5 juin 2026

Achèvement de l'étude (Estimé)

5 septembre 2026

Dates d'inscription aux études

Première soumission

10 mai 2026

Première soumission répondant aux critères de contrôle qualité

21 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AMESI-EST

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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