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Completed

NCT Number: NCT05665946

Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children

Treatment and study plan

Blood sample analysis

Diagnostic Test

Analysis of proposed biomarkers.

Primary outcomes

  1. D-lactate

    Time frame: 2015-2019, Just after inclusion

    Measurement of baseline level of D-lactate as a predictor of AIN

  2. I-FABP

    Time frame: 2015-2019, Just after inclusion

    Measurement of baseline level of I-FABP as a predictor of AIN.

  3. Endothelin-1

    Time frame: 2015-2019, Just after inclusion

    Measurement of baseline level of Endothelin-1 as a predictor of AIN

  4. L-lactate

    Time frame: 2015-2019, Just after inclusion

    Measurement of baseline level of L-lactate as a predictor of AIN

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Acute Intestinal Ischaemia: the Preoperative Diagnostic Approach

Acronym: AIN

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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