Clinical trial NCT05665946: Acute Intestinal Necrosis- the Preoperative Diagnostic Approach
Official title: Acute Intestinal Ischaemia: the Preoperative Diagnostic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Mesenteric Ischemia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 2958
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referred patient from the whole uptake area whic is 590.000 inhabitans for regional hospital functions.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Referred to The Department of Gastrointestinal Surgery, Aalborg University Hospital.

Exclusion Criteria:

* Children

Primary outcomes:
measure: D-lactate
timeFrame: 2015-2019, Just after inclusion
measure: I-FABP
timeFrame: 2015-2019, Just after inclusion
measure: Endothelin-1
timeFrame: 2015-2019, Just after inclusion
measure: L-lactate
timeFrame: 2015-2019, Just after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Gastrointestinal Surgery, Aalborg University Hospital
name: David Straarup, MD
role: PRINCIPAL_INVESTIGATOR
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