Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

Acute Mesenteric Ischemia Clinical Trial

— AIN  

Official title:

Acute Intestinal Ischaemia: the Preoperative Diagnostic Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665946
• Other study ID #: AalborgAIN
• Status: Completed
• Start date: January 6, 2015
• Est. completion date: March 24, 2019

Study information

• Verified date: December 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2958
• Est. completion date: March 24, 2019
• Est. primary completion date: March 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children

Related Conditions & MeSH terms

• Acute Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia

Intervention

Diagnostic Test:
• Blood sample analysis
Analysis of proposed biomarkers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-lactate	Measurement of baseline level of D-lactate as a predictor of AIN	2015-2019, Just after inclusion
Primary	I-FABP	Measurement of baseline level of I-FABP as a predictor of AIN.	2015-2019, Just after inclusion
Primary	Endothelin-1	Measurement of baseline level of Endothelin-1 as a predictor of AIN	2015-2019, Just after inclusion
Primary	L-lactate	Measurement of baseline level of L-lactate as a predictor of AIN	2015-2019, Just after inclusion