Acute Intestinal Necrosis- the Preoperative Diagnostic Approach (AIN)

Acute Intestinal Ischaemia: 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.

Study Overview

• Status: Completed
• Conditions: Acute Mesenteric Ischemia
• Intervention / Treatment: Diagnostic test: Blood sample analysis

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.

• Study Type: Observational
• Enrollment (Actual): 2958

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Referred patient from the whole uptake area whic is 590.000 inhabitans for regional hospital functions.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AIN patients; Surgical verified AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.	Diagnostic test: Blood sample analysis; Analysis of proposed biomarkers.
Controls.; Non-AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.	Diagnostic test: Blood sample analysis; Analysis of proposed biomarkers.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: David Straarup, MD, Dept. of Gastrointestinal Surgery, Aalborg University Hospital

Publications and helpful links

General Publications

• Adaba F, Askari A, Dastur J, Patel A, Gabe SM, Vaizey CJ, Faiz O, Nightingale JM, Warusavitarne J. Mortality after acute primary mesenteric infarction: a systematic review and meta-analysis of observational studies. Colorectal Dis. 2015 Jul;17(7):566-77. doi: 10.1111/codi.12938.
• Assadian A, Assadian O, Senekowitsch C, Rotter R, Bahrami S, Furst W, Jaksch W, Hagmuller GW, Hubl W. Plasma D-lactate as a potential early marker for colon ischaemia after open aortic reconstruction. Eur J Vasc Endovasc Surg. 2006 May;31(5):470-4. doi: 10.1016/j.ejvs.2005.10.031. Epub 2005 Dec 22.
• Block T, Nilsson TK, Bjorck M, Acosta S. Diagnostic accuracy of plasma biomarkers for intestinal ischaemia. Scand J Clin Lab Invest. 2008;68(3):242-8. doi: 10.1080/00365510701646264.
• Corcos O, Nuzzo A. Gastro-intestinal vascular emergencies. Best Pract Res Clin Gastroenterol. 2013 Oct;27(5):709-25. doi: 10.1016/j.bpg.2013.08.006. Epub 2013 Sep 5.
• Dohle DS, Bestendonk C, Petrat F, Tsagakis K, Wang M, Strucksberg KH, Canbay A, Jakob H, de Groot H. Serum markers for early detection of patients with mesenteric ischemia after cardiac surgery. Innov Surg Sci. 2018 Nov 30;3(4):277-283. doi: 10.1515/iss-2018-0035. eCollection 2018 Dec.
• Nuzzo A, Guedj K, Curac S, Hercend C, Bendavid C, Gault N, Tran-Dinh A, Ronot M, Nicoletti A, Bouhnik Y, Castier Y, Corcos O, Peoc'h K; SURVI (Structure d'URgences Vasculaires Intestinales) Research Group (French Intestinal Stroke Center). Accuracy of citrulline, I-FABP and D-lactate in the diagnosis of acute mesenteric ischemia. Sci Rep. 2021 Sep 23;11(1):18929. doi: 10.1038/s41598-021-98012-w.
• Tilsed JV, Casamassima A, Kurihara H, Mariani D, Martinez I, Pereira J, Ponchietti L, Shamiyeh A, Al-Ayoubi F, Barco LA, Ceolin M, D'Almeida AJ, Hilario S, Olavarria AL, Ozmen MM, Pinheiro LF, Poeze M, Triantos G, Fuentes FT, Sierra SU, Soreide K, Yanar H. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg. 2016 Apr;42(2):253-70. doi: 10.1007/s00068-016-0634-0.
• Reintam Blaser A, Forbes A, Bjorck M. Acute mesenteric ischaemia. Curr Opin Crit Care. 2022 Dec 1;28(6):702-708. doi: 10.1097/MCC.0000000000000972. Epub 2022 Aug 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Actual): March 24, 2019
• Study Completion (Actual): March 24, 2019

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: AalborgAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No