No registrations found.
ID
Source
Brief title
Health condition
Acute Intestinal Ischemia
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
Detection 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. We aim to validate a panel of plasma biomarkers and investigate volatile biomarkers that allow early and accurate identification of acute intestinal ischemia in patients. In addition, we aim to identify a volatile organic compound (VOC) profile specific for acute intestinal ischemia in exhaled breath.
Study objective
These patients are difficult to diagnose due to a multitude of non-specific symptoms and the lack of fast and specific tests. In this study we will be able to investigate patients that are admitted with acute abdominal complications and observe them in the early stages of their condition. Accordingly, we will be able to evaluate the proposed panel of biomarkers and to identify VOC patterns in patients with acute abdominal complications. Therefore, we propose that with this study we will be able to improve the diagnostic accuracy of acute intestinal ischemia, and will provide more information that guides adequate treatment.
Study design
11
Intervention
There will be no interventions in this study.
Inclusion criteria
Age ≥ 18 years
All consecutive patients admitted to one of the participating medical centers emergency departments (ED) or at the intensive care unit (ICU) 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
Age ≤ 18 years
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7968 |
| Other | METC azM/UM : METC 19-010 |