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Recruiting NCT07610356

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

Observational Non-Occlusive Mesenteric Ischaemia (NOMI) Acute Mesenteric Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Non-Occlusive Mesenteric Ischaemia (NOMI), Acute Mesenteric Ischemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Estonia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index [Time frame: Baseline]
  • Predictors of transmural necrosis in NOMI patients - SOFA score [Time frame: Baseline]
  • Predictors of transmural necrosis in NOMI patients - GRV [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - bloody stool. [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - cardiac arrest. [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - RRT [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - WBC. [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - CRP [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - lactate [Time frame: Baseline]
  • Predictors of transmural ischemia in NOMI patients - pneumatosis intestinalis [Time frame: Baseline]
Secondary outcome measures (4)
  • CT findings in patients with suspected AMI [Time frame: Baseline]
  • Management of AMI patients [Time frame: Baseline]
  • 30-day survival [Time frame: 30 days after admission]
  • 90-day survival [Time frame: 90 days after admission]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Estonia · 2 centers
  • North Estonia Medical Centre — Tallinn
  • Tartu University Hospital — Tartu

Identifiers

NCT: NCT07610356 · AMESI-EST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗