ClinicalTrials.gg
CompletedNCT05665946AINUpdated Dec 29, 2022

Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

An observational study in Acute Mesenteric Ischemia, sponsored by Aalborg University Hospital. Completed. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-12-29.

Sponsored by Aalborg University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,958
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Acute Mesenteric Ischemia

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03

In context

Mesenteric Ischemia

40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.

This study's enrollment of 2,958 is above the median of 154 across 26 observational studies indexed under Mesenteric Ischemia.

Browse Mesenteric Ischemia studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,958 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testBlood sample analysis

    Analysis of proposed biomarkers.

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What researchers measure

Primary outcomes

  1. D-lactate

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

    Time frame: 2015-2019, Just after inclusion

  2. I-FABP

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

    Time frame: 2015-2019, Just after inclusion

  3. Endothelin-1

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

    Time frame: 2015-2019, Just after inclusion

  4. L-lactate

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

    Time frame: 2015-2019, Just after inclusion

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 25739990 ↗
  • 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. PubMed 16376117 ↗
  • 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. PubMed 17934974 ↗
  • 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. PubMed 24160929 ↗
  • 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. PubMed 31579792 ↗
  • 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. PubMed 34556697 ↗
  • 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. PubMed 26820988 ↗
  • 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. PubMed 35950719 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05665946
Responsible party
David Straarup (Principal Investigator, Aalborg University Hospital) — Principal investigator
First posted
Dec 27, 2022
Start date
Jan 6, 2015
Primary completion
Mar 24, 2019
Completion
Mar 24, 2019
Last update
Dec 29, 2022

Study contacts

David Straarup, MD
principal investigator · Dept. of Gastrointestinal Surgery, Aalborg University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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