The Detrimental Course of Acute Intestinal Ischemia

Summary

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.

Conditions

• Diagnoses Disease
• Acute Mesenteric Ischemia
• Intestinal Disease

Interventions

OTHER

Biomarker validation and VOC profile identification

Validation of a panel of plasma markers for the early diagnosis of acute intestinal ischemia with a panel consists of I-FABP, VIL-1, and SM22. Identification of an acute intestinal ischemia specific VOCs profile and evaluate exhaled breath analysis as a diagnostic tool for intestinal ischemia.

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• Maag Lever Darm Stichting

  collaborator OTHER

• Maastricht University

  lead OTHER

Principal Investigators

• Annet Duivenvoorden, MSc · Maastricht University

• Kaatje Lenaerts, PhD · Maastricht University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-15

Primary Completion

2023-09-15

Completion

2024-09-15

Countries

• Belgium
• Netherlands

Study Locations