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Acute Mesenteric IschemiaAINNCT05665946

Acute Intestinal Necrosis- the Preoperative Diagnostic Approach

An observational study of Acute Mesenteric Ischemia, run by Aalborg University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Acute Mesenteric Ischemia
What is being tested?
Blood sample analysis
How many people
2,958 participants
Where
No sites listed yet
Study dates
6 Jan 2015to 24 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Children

About this study

Official title: 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.

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.

Being tested
Blood sample analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sample analysisDiagnostic test

    Analysis of proposed biomarkers.

Study groups in NCT05665946
Study groupRoleWhat they receive
AIN patientsSurgical verified AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.
Receives: Diagnostic Test: Blood sample analysis
Controls.Non-AIN patients. A blood sample is drawn just after inclusion and stored for later analysis.
Receives: Diagnostic Test: Blood sample analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. D-lactate

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

    Measured: 2015-2019, Just after inclusion

  2. I-FABP

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

    Measured: 2015-2019, Just after inclusion

  3. Endothelin-1

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

    Measured: 2015-2019, Just after inclusion

  4. L-lactate

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

    Measured: 2015-2019, Just after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start6 Jan 2015
  3. Primary completion24 Mar 2019
  4. Study completion24 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,958 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665946
Sponsor's protocol ID
AalborgAIN
Acronym
AIN
Status last verified
Dec 2022
First submitted
9 Dec 2022
Last updated
29 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 37403410

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Mesenteric Ischemia, run by Aalborg University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

D-lactate (time frame: 2015-2019, Just after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665946, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.

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