We aim to validate a panel of plasma biomarkers and investigate volatile biomarkers that potentially allow early and accurate identification of acute intestinal ischemia in patients. Second, we aim to identify a volatile organic compound (VOC)…
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the early and accurate identification of
presence and severity of acute intestinal ischemia in patients. The main study
parameters are plasma biomarkers indicative for intestinal damage of patients
suspected of acute intestinal ischemia.
Secondary outcome
The secundary study paramater is the identfication of volatile organic
compounds (VOC) in exhaled air of patients suspected of acute intestinal
ischemia.
Background summary
Acute intestinal ischemia is a life-threatening condition with a short-term
mortality that can range up to 80%. Medical diagnosis and treatment have
remained troublesome, due to the clinical presentation which is mostly
characterized by non-specific signs and symptoms. Early unambiguous diagnosis
of acute intestinal ischemia is critical to prevent progression from reversible
to irreversible intestinal injury, and henceforth decrease morbidity and
improve survival.
Study objective
We aim to validate a panel of plasma biomarkers and investigate volatile
biomarkers that potentially allow early and accurate identification of acute
intestinal ischemia in patients. Second, we aim to identify a volatile organic
compound (VOC) profile specific for acute intestinal ischemia in exhaled
breath.
Study design
Prospective observational study
Study burden and risks
There is a minimal amount of risks involved in participating in this study.
Blood samples will be obtained with the use of an arterial line, intravenous
line (IV), central venous catheter (CVC), peripheral venous catheter (PVC) or a
venepuncture. The risk of venepuncture is a small local hematoma. In addition
to blood sampling, we will also obtain exhaled air. This non-invasive procedure
takes approximately 5 minutes in which patients breath in a 3L Tedlar bag at a
normal frequency and volume. This procedure will not cause any physical strain.
Collection of samples and data will take place during the hospital stay of the
included patients. For this reason, no additional hospital visits are required
for this study. Participating patients in this study will have no direct
benefits, but in the future the results of our study will likely be useful in
the early diagnosis of patients suspected of acute intestinal ischemia.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
The following inclusion criteria will be used:
Age >= 18 years
All consecutive patients admitted to one of the participating medical centers
emergency departments (ED) or at the intensive care unit (ICU) (see 4.1
Population Base) with clinical suspicion of acute intestinal ischemia, which is
based on;
o clinical manifestation;
o physical examination by the physician;
o laboratory measurements;
o physician*s consideration to perform computed tomography (CT)-scan
Exclusion criteria
Younger than 18 years of age
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 | NL68026.068.19 |