NCT05194527: TACTIC

The Detrimental Course of Acute Intestinal Ischemia

Status unknown Last updated 18 January 2022

What this trial tests

trial testing Biomarker validation and VOC profile identification in Diagnoses Disease in 120 participants. Status unknown.

Timeline

15 September 2020

Primary endpoint
15 September 2023

15 September 2024

Quick facts

Lead sponsor	Maastricht University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	120
Start date	15 September 2020
Primary completion	15 September 2023
Estimated completion	15 September 2024
Sites	6 locations across Belgium, Netherlands

Drugs / interventions tested

• Biomarker validation and VOC profile identification

Conditions studied

• Diagnoses Disease — all drugs for Diagnoses Disease →
• Acute Mesenteric Ischemia — all drugs for Acute Mesenteric Ischemia →
• Intestinal Disease — all drugs for Intestinal Disease →

Sponsor

Maastricht University

Who can join

18 and older, any sex, with Diagnoses Disease or Acute Mesenteric Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Managing acute mesenteric ischaemia.
   Reintam Blaser A, Coopersmith CM, Acosta S. · · 2024 · cited 10× · PMID 38478026 · DOI 10.1007/s00134-024-07363-1
2. Diagnostic potential of plasma biomarkers and exhaled volatile organic compounds in predicting the different stages of acute mesenteric ischaemia: protocol for a multicentre prospective observational study (TACTIC study).
   Duivenvoorden AAM, Clarysse M, Ceulemans LJ, Geelkerken RH, et al · · 2023 · cited 6× · PMID 37643848 · DOI 10.1136/bmjopen-2023-072875
3. Intestinal Fatty Acid Binding Protein as a Predictor of Early Mesenteric Injury Preceding Clinical Presentation: A Case Report.
   Duivenvoorden AAM, Metz FM, Wijenbergh R, Verberght HCR, et al · · 2024 · cited 2× · PMID 38884076 · DOI 10.1016/j.ejvsvf.2024.04.004