Evaluation of I-FABP as diagnostic tool in mesenteric ischemia.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnosis, CT-angiography, moment of surgery, I-FABP concentration in blood
and urine samples
Secondary outcome
Mortality, final diagnosis, unnecessary surgery (negative laparotomy/ scopy)
Background summary
Mesenteric ischemia is a severe disease accompanied with a substantial
morbidity and mortality of up to 40%-70%. Early diagnosis is essential to give
adequate treatment and to prevent severe and irreversible intestinal damage.
However, diagnosis of mesenteric ischemia is challenging, especially in the
early stage of the disease due to its aspecific symptoms. Clinical symptoms can
vary between vague abdominal complaints to signs of peritonitis caused by
transmural ischemia.
The incidence of acute mesenteric ischemia is estimated to be 0,5% of all
hospital admissions, with a marignal increase due to the increasing number of
elderly patients. An arterial embolus or thrombosis causes mesenteric ischemia
in 70-80% of cases. The superior mesenteric artery is occluded in most cases.
Laboratory investigation typically shows a leucocytosis and a metabolic
acidosis. Markers such as (D)-lactate and D-dimers can also be elevated,
however these markers are not specific.
CT-angiography is the gold standard at this moment for diagnosing acute
mesenteric ischemia with a good sensitivity and good specificity. However,
CT-angiography is accompanied with several disadvantages such as radiation,
renal impairment and a potential allergic response to the iv-contrast. Since
the clinical symptoms are not always very clear and rapid intervention is of
the essence, many patients with a suspicion of mesenteric ischemia are
subjected to a CT-angiography, however with a negative outcome. Furthermore, it
is unknown whether the high sensitivity and specificity as described in the
literature in the expert centres can be extrapolated to daily practice.
Intestinal-Fatty Acid Binding Protein (I-FABP) is a cytosolic protein which is
present in the intestinal epithelial cell. It is clearly elevated in blood and
urine samples when intestinal damage occurs. Previous experimental studies have
shown that the amount of I-FABP is predictive of mesenteric ischemia and
correlates well with the extent of intestinal damage. In this study we
investigate whether I-FABP can be used as a diagnostic tool in mesenteric
ischemia as compared with the gold standard (CT-angiography).
Study objective
Evaluation of I-FABP as diagnostic tool in mesenteric ischemia.
Study design
Blood and urine samples will be taken from subjects suspected of mesenteric
ischemia at the time of diagnosis (day 0) and after 1 and 5 days.
Values of I-FABP in blood and urine will be correlated to results of the
CT-angiography and clinical outcome.
Study burden and risks
Venous puncture will be performed (3x). This will mostly be part of the regular
blood sampling. Collection of urine is without risks.
Benefit: this study will contribute to a better diagnosis of mesenteric
ischemia in the future.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Age >18 years
Suspicion of acute mesenteric ischemia
Signed informed consent
Exclusion criteria
Patients that underwent abdominal surgery within 7 days prior to presentation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37101.060.11 |