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Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia (AMESI-EST)

2026年5月21日 更新者:Vladislav Mihnovitš、University of Tartu

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.

研究概览

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tallinn
      • Tallinn、Tallinn、爱沙尼亚、13419
    • Tartu
      • Tartu、Tartu、爱沙尼亚、50406

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

All adult patients who develop suspicion of acute mesenteric ischemia during their ICU stay will be included in the study. The study will take place in the ICUs of the two largest hospitals in Estonia: Tartu University Hospital and North Estonian Medical Centre.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Predictors of transmural necrosis in NOMI - age-adjusted Charlson comorbidity index
大体时间: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
大体时间: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
大体时间: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.
大体时间: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.
大体时间: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
大体时间: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.
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
CT findings in patients with suspected AMI
大体时间:Baseline

Computed tomography variables in patients with suspicion of acute mesenteric ischemia will be analysed.

Variables:

  • Presence of bowel dilatation (Yes or No variable)
  • Pathological bowel wall enhancement (categorization: absence or decrease enhancement; normal enhancement; increased enhancement)
  • Presence of pneumatosis intestinalis (Yes or No variable)
  • Presence of gas in the mesenteric or portal venous system (Yes or No variable)
  • Thickening of the bowel wall (Yes or No variable) (small bowel > 3 mm, large bowel > 3 mm if distended or > 5 mm if not distended)
  • Thinning of the bowel wall (Yes or No variable)
Baseline
Management of AMI patients
大体时间:Baseline
Rate of surgical, conservative, endovascular or palliative management
Baseline
30-day survival
大体时间: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
大体时间:90 days after admission
90-day Survival of patients with suspicion of acute mesenteric ischemia in the ICU
90 days after admission

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年6月6日

初级完成 (估计的)

2026年6月5日

研究完成 (估计的)

2026年9月5日

研究注册日期

首次提交

2026年5月10日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AMESI-EST

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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