Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

NCT05665946 | Completed

• 1 other identifier: AalborgAIN
• Study Type: observational
• Target: 2,958
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Mesenteric Ischemia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

AIN patients

Surgical verified AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.

Diagnostic Test: Blood sample analysis

Controls.

Non-AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.

Diagnostic Test: Blood sample analysis

Interventions

Blood sample analysis DIAGNOSTIC_TEST

Analysis of proposed biomarkers.

AIN patients; Controls.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Children

Sponsors & Collaborators

• Aalborg University Hospital: lead

Related Publications (9)

• 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.

  PMID: 25739990 BACKGROUND

• 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.

  PMID: 16376117 BACKGROUND

• 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.

  PMID: 17934974 BACKGROUND

• 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.

  PMID: 24160929 BACKGROUND

• 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.

  PMID: 31579792 BACKGROUND

• 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.

  PMID: 34556697 BACKGROUND

• 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.

  PMID: 26820988 BACKGROUND

• 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.

  PMID: 35950719 BACKGROUND

• Straarup D, Gotschalck KA, Christensen PA, Krarup H, Lundbye-Christensen S, Handberg A, Thorlacius-Ussing O. Exploring I-FABP, endothelin-1 and L-lactate as biomarkers of acute intestinal necrosis: a case-control study. Scand J Gastroenterol. 2023 Jul-Dec;58(12):1359-1365. doi: 10.1080/00365521.2023.2229930. Epub 2023 Jul 4.

  PMID: 37403410 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood samples drawn just after inclusion.

Study Officials

• David Straarup, MD

  Dept. of Gastrointestinal Surgery, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 27, 2022
• Study Start: January 6, 2015
• Primary Completion: March 24, 2019
• Study Completion: March 24, 2019
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share