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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Tallinn
-
Tallinn, Tallinn, Estland, 13419
- Rekrytering
- North Estonia Medical Centre
-
Kontakt:
- Olga Kiss, MD
- Telefonnummer: +372 617 1300
- E-post: Olga.Kiss@regionaalhaigla.ee
-
-
Tartu
-
Tartu, Tartu, Estland, 50406
- Rekrytering
- Tartu University Hospital
-
Kontakt:
- Vladislav Mihnovitš, MD
- Telefonnummer: +372 7318111
- E-post: vladislav.mihnovits@kliinikum.ee
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CT findings in patients with suspected AMI
Tidsram: Baseline
|
Computed tomography variables in patients with suspicion of acute mesenteric ischemia will be analysed. Variables:
|
Baseline
|
|
Management of AMI patients
Tidsram: Baseline
|
Rate of surgical, conservative, endovascular or palliative management
|
Baseline
|
|
30-day survival
Tidsram: 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
Tidsram: 90 days after admission
|
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
|
90 days after admission
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AMESI-EST
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .