Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

Study Overview
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Brief Summary
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To investigate a number of blood based parameters in patients with intestinal ischaemia compared to patients with other acute abdominal diseases.

Detailed Description
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Intestinal ischemia is a life-threatening condition defined by interrupted blood supply to the intestinal tissue. Primary and secondary ischemia is obstruction of blood-supply due to vascular and extra-vascular pathology, respectively. Early diagnosis and treatment are critical to save the ischemic bowel. Clinical findings of secondary intestinal ischaemia are related to the underlying cause e.g. vomiting and palpable hernia. Abdominal computed tomography (CT) can effectively visualize the causes. In contrast, the diagnosis of primary intestinal ischemia is often delayed due to the absence of specific clinical findings. Primary intestinal ischemia is visualized with CT ateriography, revealing mesentery arterial obstruction. However, in the acute setting a non-arterial phase CT is often performed but the findings are unspecific in the early stages and the pattern of findings which could indicate primary ischemia are not well understood. In primary and secondary ischemia, standard blood-based parameters are inconsistently elevated and highly unspecific. Newer blood-based parameters such as D-lactate has been proposed as ischaemic markers. D-lactate is produced by bacteria in the bowel lumen and translocation through a damaged bowel wall makes it a potential marker of intestinal ischemia. A case-control-study of all acute admitted patients with abdominal pain in Aalborg, Denmark in the mentioned time range. The sensitivity and specificity of potiential biomarkers in a blood sample at time of admission as a marker of intestinal ischaemia will be examined.

Official Title
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Acute Intestinal Ischaemia: the Preoperative Diagnostic Approach

Conditions
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Acute Mesenteric Ischemia

Intervention / Treatment
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* Diagnostic Test: Blood sample analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to The Department of Gastrointestinal Surgery, Aalborg University Hospital. Exclusion Criteria: Children

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AIN patients<br>Surgical verified AIN patients. A blood sample is drawn just after inclusion and stored for later analysis. | Diagnostic Test: Blood sample analysis<br>* Analysis of proposed biomarkers.<br>|
| Controls.<br>Non-AIN patients. A blood sample is drawn just after inclusion and stored for later analysis. | Diagnostic Test: Blood sample analysis<br>* Analysis of proposed biomarkers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-lactate | Measurement of baseline level of D-lactate as a predictor of AIN | 2015-2019, Just after inclusion | 
| I-FABP | Measurement of baseline level of I-FABP as a predictor of AIN. | 2015-2019, Just after inclusion | 
| Endothelin-1 | Measurement of baseline level of Endothelin-1 as a predictor of AIN | 2015-2019, Just after inclusion | 
| L-lactate | Measurement of baseline level of L-lactate as a predictor of AIN | 2015-2019, Just after inclusion |