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

Active, not recruiting

• Conditions: Non-Occlusive Mesenteric Ischemia

• Registration Number: NCT06970015
• Lead Sponsor: University of Tartu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-06
• Primary Completion: 2023-04-05
• Study First Submitted: 2025-04-18
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic profile	Baseline	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)
SOFA score	Baseline	Sequential Organ Failure Assessment (SOFA) score. Range: 0-24. Higher scores indicate more severe organ dysfunction.
Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia	Baseline	Serum lactate level measured in mmol/L. Higher values indicate worse tissue perfusion.
Baseline APACHE II Score	Baseline	Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Range: 0-71. Higher scores indicate more severe disease and higher predicted mortality.
Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia	Baseline	Arterial pH level. Normal range is 7.35-7.45. Lower values indicate acidosis.

Secondary Outcome Measures

Name	Time	Method
Rate of Patients Diagnosed with Non-Occlusive Mesenteric Ischemia by CT, Endoscopy, or Angiography	Baseline	Percentage of participants diagnosed with non-occlusive mesenteric ischemia (NOMI) using computed tomography (CT), endoscopy, or angiography.
Management	Baseline	Rate of surgical, conservative, endovascular or palliative management
30-day survival	30 days after admission	30-day Survival of patients with non-occlusive mesenteric ischemia
1-year survival	1 year	1-year survival of patients with non-occlusive mesenteric ischemia

Trial Locations

Locations (1)

University of Tartu; 🇪🇪 Tartu, Estonia