- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610356
Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia (AMESI-EST)
Mesenteric Ischemia in the ICU: A Prospective Observational Study Across Estonian Regional Hospitals
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Tallinn
-
Tallinn, Tallinn, Estonia, 13419
- Recruiting
- North Estonia Medical Centre
-
Contact:
- Olga Kiss, MD
- Phone Number: +372 617 1300
- Email: Olga.Kiss@regionaalhaigla.ee
-
-
Tartu
-
Tartu, Tartu, Estonia, 50406
- Recruiting
- Tartu University Hospital
-
Contact:
- Vladislav Mihnovitš, MD
- Phone Number: +372 7318111
- Email: vladislav.mihnovits@kliinikum.ee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with suspected acute mesenteric ischemia in the ICU
|
This is a prospective observational study on ICU patients with the suspicion of acute mesenteric ischemia.
No intervention is done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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.
Time Frame: Baseline
|
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.
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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.
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CT findings in patients with suspected AMI
Time Frame: Baseline
|
Computed tomography variables in patients with suspicion of acute mesenteric ischemia will be analysed. Variables:
|
Baseline
|
|
Management of AMI patients
Time Frame: Baseline
|
Rate of surgical, conservative, endovascular or palliative management
|
Baseline
|
|
30-day survival
Time Frame: 30 days after admission
|
30-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
|
30 days after admission
|
|
90-day survival
Time Frame: 90 days after admission
|
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
|
90 days after admission
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMESI-EST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Mesenteric Ischemia
-
University Hospital, Strasbourg, FranceRecruitingAcute Mesenteric IschemiaFrance
-
Assistance Publique Hopitaux De MarseilleRecruiting
-
University of TartuRecruiting
-
University of TartuCompletedAcute Mesenteric IschemiaSwitzerland, Estonia
-
University of TartuRecruitingAcute Mesenteric IschemiaEstonia
-
Hospital del MarHospital Clinic of Barcelona; Germans Trias i Pujol Hospital; Hospital Arnau... and other collaboratorsNot yet recruitingAcute Mesenteric Ischemia
-
Hospital del MarNot yet recruitingAcute Mesenteric Ischemia
-
Assistance Publique - Hôpitaux de ParisRecruitingAcute Mesenteric IschemiaFrance
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Aalborg University HospitalCompletedAcute Mesenteric Ischemia
Clinical Trials on Observation
-
Ariel UniversityCompleted
-
National Taiwan Normal UniversityRecruitingPhysical Fitness | Event-Related Potentials | Executive Function (Cognition)Taiwan
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Ministry of Health, Italy; European Union; Alleanza Contro il Cancro; Associazione...RecruitingHead and Neck Cancer | Nasopharynx Cancer | Salivary Gland Cancer | Nasal Cavity and Paranasal Sinus Cancer | Middle Ear CarcinomaItaly, Czechia, Germany
-
Second Affiliated Hospital, School of Medicine,...Completed
-
University of MichiganKuwait Foundation for the Advancement of SciencesCompletedGingival RecessionUnited States
-
University of RzeszowCompleted
-
National Taiwan Normal UniversityRecruitingProspective Study | Event-Related Potentials | Older Adults (65 Years and Older) | Executive Function (Cognition) | Fitness TestingTaiwan
-
Beijing Tiantan HospitalPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsCompleted
-
Istanbul University - Cerrahpasa (IUC)CompletedBrachial Plexus Palsy | Obstetric; InjuryTurkey
-
Centre Hospitalier Régional d'OrléansCompleted