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Role of intestinal fatty acid binding protein (I-FABP) in diagnosing acute mesenteric ischemia.


- candidate number10276
- NTR NumberNTR3036
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2011
- Secondary IDsM11-1125 METC Eindhoven
- Public TitleRole of intestinal fatty acid binding protein (I-FABP) in diagnosing acute mesenteric ischemia.
- Scientific TitleRole of intestinal fatty acid binding protein (I-FABP) in diagnosing acute mesenteric ischemia.
- ACRONYMFAMOUS
- hypothesisiFABP can be used as a primary diagnostic tool to detect and exclude mesenteric ischemia.
- Healt Condition(s) or Problem(s) studiedMesenteric ischemia
- Inclusion criteria1. Age ≥ 18 jaar;
2. Suspection of acute mesenteric ischemia;
3. Signed informed consent.
- Exclusion criteriaPrevious abdominal surgery within 1 week of presentation.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2011
- planned closingdate1-okt-2013
- Target number of participants263
- InterventionsN/A
- Primary outcomeI-FABP concentraties in blood and urine compared with result of CT-angiography and surgery.
- Secondary outcome1. Mortality;
2. Negative laparotomy;
3. Other diagnosis.
- TimepointsDay of presentation (0);
Day 1;
Day 5.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Misha Luyer
- CONTACT for SCIENTIFIC QUERIES Misha Luyer
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- Publications1. Oldenburg WA, Lau LL, Rodenberg TJ, Edmonds HJ, Burger CD. Acute mesenteric ischemia: a clinical review. Arch Intern Med 2004;164:1054-62.PMID 15159262.
2. Kassahun WT, Schulz T, Richter O, Hauss J. Unchanged high mortality rates from acute occlusive intestinal ischemia: six year review. Langenbecks Arch Surg 2008;393:163-71.PMID 18172675.
3. Sise MJ. Mesenteric ischemia: the whole spectrum. Scand J Surg;99:106-10.PMID 20679047 4. Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg;253:303-8.PMID 21245670.
5. Menke J. Diagnostic accuracy of multidetector CT in acute mesenteric ischemia: systematic review and meta-analysis. Radiology;256:93-101.PMID 20574087.
6. Thuijls G, Derikx JP, van Wijck K, Zimmermann LJ, Degraeuwe PL, Mulder TL, Van der Zee DC, Brouwers HA, Verhoeven BH, van Heurn LW, Kramer BW, Buurman WA, Heineman E. Non-invasive markers for early diagnosis and determination of the severity of necrotizing enterocolitis. Ann Surg;251:1174-80.PMID 20485148.
- Brief summaryMesenteric ischemia is a potentially lethal condition in which early diagnosis is pivotal. Since simple and readily available diagnostic tools are lacking, mesenteric ischemia is still accompanied with a high morbidity and mortality.
CT-angiography is the golden standard to assess acute mesenteric ischemia with a good sensitivity and good specificity. However, a CT-angiography is associated with important disadvantages for the patient and since the early presentation may be atypical, a CT-angiography is often performed at a later stage of the disease. Intestinal-Fatty Acid Binding Protein (I-FABP) is a cytosolic protein that resides in the intestinal epithelial cell en is detectable in urine and blood during intestinal ischemia. In previous experimental and clinical studies has been shown that iFABP values in blood and urine strongly correlate with intestinal damage and ischemia. In this study we will investigate whether iFABP can be used as a primary diagnostic tool to detect and exclude mesenteric ischemia. I-FABP concentrations in plasma will be correlated to the results of CT-angiography and/ or surgery in a multicentre setting.
- Main changes (audit trail)
- RECORD24-aug-2011 - 9-sep-2011


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