Diagnoses Disease Clinical Trial
— TACTICOfficial title:
The Detrimental Course of Acute Intestinal Ischemia: Improvement of the Diagnosis
Rationale: 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. Objective: 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 design: Prospective observational study Study population: All patients suspected of acute intestinal ischemia Main study parameters: 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 and volatile organic compounds (VOC) in exhaled air of patients suspected of acute intestinal ischemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. The research goal in this study is the early identification of patients that suffer from acute intestinal ischemia. 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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 15, 2024 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) (see 4.1 Population Base) with clinical suspicion of acute intestinal ischemia, which is based on; - clinical manifestation; - physical examination by the physician; - laboratory measurements; - physician's consideration to perform computed tomography (CT)-scan Exclusion Criteria: A subject who meets any of the following criteria will be excluded from participation in this study: - Age = 18 years In order to evaluate the performance of the panel of markers for the acute intestinal ischemia in clinical practice, the study population must resemble the clinical patient population as closely as possible |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Leuven | Leuven | Vlaams-Brabant |
Netherlands | Amsterdam University Medical Centre (UMC) - Location AMC | Amsterdam | Noord-Holland |
Netherlands | Amsterdam University Medical Centre (UMC) - Location VUMC | Amsterdam | Noord-Holland |
Netherlands | Gelre Ziekenhuizen | Apeldoorn | Gelderland |
Netherlands | University Medical Centre Groningen (UMCG) | Groningen | |
Netherlands | Maastricht University Medical Centre+ (MUMC=) | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Gelre Hospitals, Maag Lever Darm Stichting, Maastricht University Medical Center, Medisch Spectrum Twente, Universitaire Ziekenhuizen Leuven, University Medical Center Groningen |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main study parameters are plasma biomarkers indicative for intestinal damage of patients suspected of acute intestinal ischemia. | The primary outcome parameter in this study is the optimal cut-off values (from the combined plasma biomarkers) for classifying clinical cases that are positive or negative for acute intestinal ischemia. | Inclusion (T0 min), 60 min (T60), 120 min (T120), 180 min (T180), Preoperative (PREOP), Reperfusion (RPF), Day 1 (T1), Day 2 (T2), Day 3 (T3), Day 4 (D4), Day 5 (D5) | |
Secondary | Secondary parameters in this study are the expression of VOCs in exhaled air of patients suspected of acute intestinal ischemia. | The secondary outcome in this study is the identification of specific VOC profiles for ischemia vs. non-ischemia patients. The individual compounds of this VOC profile are identified in order to discover novel pathophysiologic pathways involved in intestinal ischemia | Inclusion (T0 min), 60 min (T60), 120 min (T120), 180 min (T180), Preoperative (PREOP), Reperfusion (RPF), Day 1 (T1), Day 2 (T2), Day 3 (T3), Day 4 (D4), Day 5 (D5) |
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