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

NCT07610356 | Recruiting

• 1 other identifier: AMESI-EST
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

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

Keywords

Acute mesenteric ischemia; non-occlusive mesenteric ischemia; transmural necrosis; predictors

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (4)

• CT findings in patients with suspected AMI

  Baseline

• Management of AMI patients

  Baseline

• 30-day survival

  30 days after admission

• 90-day survival

  90 days after admission

Study Arms (1)

Patients with suspected acute mesenteric ischemia in the ICU

Other: Observation

Interventions

Observation OTHER

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

Patients with suspected acute mesenteric ischemia in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Adult ICU patients in whom clinical suspicion of acute mesenteric ischemia is raised during their ICU stay.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (2)

North Estonia Medical Centre

Tallinn, Tallinn, 13419, Estonia

RECRUITING

Tartu University Hospital

Tartu, Tartu, 50406, Estonia

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 28, 2026
• Study Start: June 6, 2022
• Primary Completion: June 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)