Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia.

NCT06970015 | Active Not Recruiting

• 1 other identifier: NOMI-AMESI
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective multicenter observational study, conducted between June , 2022, and April, 2023, is a preplanned analysis of the AMESI study titled 'Demographics, diagnosis, management, and outcomes of non-occlusive mesenteric ischemia,' aiming primarily to describe the demographic profile, clinical presentation, and laboratory findings of patients with non-occlusive mesenteric ischemia (NOMI), and secondarily to identify independent risk factors as well as diagnostic approaches, management strategies, and outcomes-including in-hospital, 90-day, and one-year results.

Conditions

Non-Occlusive Mesenteric Ischemia

Outcome Measures

Primary Outcomes (5)

• Demographic profile

  One of the primary objectives is to describe the baseline demographic profile of patients with non-occlusive mesenteric ischemia. The demographic data will include the following information: 1. Gender (Male or Female) 2. Age (in years) 3. BMI (calculated from body weight in kilograms and height in centimeters)

  Baseline

• SOFA score

  Sequential Organ Failure Assessment (SOFA) score. Range: 0-24. Higher scores indicate more severe organ dysfunction.

  Baseline

• Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia

  Serum lactate level measured in mmol/L. Higher values indicate worse tissue perfusion.

  Baseline

• Baseline APACHE II Score

  Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Range: 0-71. Higher scores indicate more severe disease and higher predicted mortality.

  Baseline

• Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia

  Arterial pH level. Normal range is 7.35-7.45. Lower values indicate acidosis.

  Baseline

Secondary Outcomes (4)

• Rate of Patients Diagnosed with Non-Occlusive Mesenteric Ischemia by CT, Endoscopy, or Angiography

  Baseline

• Management

  Baseline

• 30-day survival

  30 days after admission

• 1-year survival

  1 year

Study Arms (5)

Patients with non-occlusive mesenteric ischemia

Patients with non-occlusive mesenteric ischemia, n=55

Other: No intervention

Patients with arterial occlusive mesenteric ischemia

Patients with arterial occlusive mesenteric ischemia, n=231

Other: No intervention

Patients with venous occlusive mesenteric ischemia

Patients with arterial occlusive mesenteric ischemia, n=73

Other: No intervention

Patients with unclear mechanism of acute mesenteric ischemia

Patients with unclear mechanism of acute mesenteric ischemia, n=48

Other: No intervention

Patients with suspected but not confirmed acute mesenteric ischemia

Patients with suspected but not confirmed acute mesenteric ischemia, n=159

Other: No intervention

Interventions

No intervention OTHER

No intervention, this is an observational study on patients with suspected acute mesenteric ischemia

Patients with arterial occlusive mesenteric ischemia; Patients with non-occlusive mesenteric ischemia; Patients with suspected but not confirmed acute mesenteric ischemia; Patients with unclear mechanism of acute mesenteric ischemia; Patients with venous occlusive mesenteric ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study groups * Patients with non-occlusive mesenteric ischemia. * Patients with arterial occlusive AMI * Patients with venous occlusive AMI * Patients with unclear mechanism of AMI * Patients with suspected but not confirmed AMI * Patients with suspected but not confirmed acute mesenteric ischemia * Patients with suspected but not confirmed acute mesenteric ischemia treated in the ICU

You may qualify if:

• All at least 18-year-old patients with acute mesenteric ischemia or patients suspected of acute mesenteric ischemia that was not confirmed
• Patients with arterial occlusive AMI
• Patients with non-occlusive mesenteric ischemia
• Patients with venous occlusive AMI
• Patients with unclear mechanism of AMI
• Patients with suspected but not confirmed AMI

You may not qualify if:

• Patients with other specific form of AMI (e.g dissection)
• Confirmed strangulating bowel obstruction
• Individuals under 18 years of age.
• Consent declined by patient or next of kin
• Chronic mesenteric ischaemia without an acute event

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

University of Tartu

Tartu, 50090, Estonia

Location

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: April 18, 2025
• First Posted: May 14, 2025
• Study Start: June 6, 2022
• Primary Completion: April 5, 2023
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

ES (1)