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NCT Number: NCT06970015

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Occlusive Mesenteric Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tartu

Tartu, 50090, Estonia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Demographic profile

    Time frame: 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:

    • Gender (Male or Female)
    • Age (in years)
    • BMI (calculated from body weight in kilograms and height in centimeters)

  2. SOFA score

    Time frame: Baseline

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

  3. Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia

    Time frame: Baseline

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

  4. Baseline APACHE II Score

    Time frame: Baseline

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

  5. Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: Baseline

    Percentage of participants diagnosed with non-occlusive mesenteric ischemia (NOMI) using computed tomography (CT), endoscopy, or angiography.

  2. Management

    Time frame: Baseline

    Rate of surgical, conservative, endovascular or palliative management

  3. 30-day survival

    Time frame: 30 days after admission

    30-day Survival of patients with non-occlusive mesenteric ischemia

  4. 1-year survival

    Time frame: 1 year

    1-year survival of patients with non-occlusive mesenteric ischemia

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia: a Substudy of a Prospective Multicenter Observational Study (AMESI)

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.