The Detrimental Course of Acute Intestinal Ischemia

NCT05194527 | Unknown

• 1 other identifier: TACTIC study
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 6

Brief 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

Keywords

Acute Mesenteric Ischemia; Volatile Organoic Compounds; Plasma/Serum Biomarkers; SM22; Villin-1; I-FABP; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary parameters in this study are the expression of VOCs in exhaled air of patients suspected of 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)

Study Arms (2)

Patients with Acute Mesenteric Ischemia

Patients that are diagnosed with Acute mesenteric Ischemia

Other: Biomarker validation and VOC profile identification

Patient with another underlying disease/condition

Patients that are diagnosed not with acute mesenteric ischemia, but with a other underlying disease/condition

Other: Biomarker validation and VOC profile identification

Interventions

Biomarker validation and VOC profile identification OTHER

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.

Patient with another underlying disease/condition; Patients with Acute Mesenteric Ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients, clinically suspected of intestinal ischemia attending Maastricht University Medical Centre+ (MUMC+, Maastricht, The Netherlands), Amsterdam UMC (VUmc/AMC, Amsterdam, The Netherlands), Gelre Ziekenhuizen Apeldoorn (Apeldoorn, The Netherlands), Medisch Spectrum Twente (MST, Enschede, The Netherlands), University Medical Centrum Groningen (UMCG) and University Hospitals Leuven (UZ, Leuven, Belgium). The clinical course of all patients will be monitored. Diagnosis of intestinal ischemia will be based on findings from physical examination, laboratory measurements, surgery or autopsy, and verified by histopathological examination of the intestine by experienced pathologists, as well as evaluation of computed tomography (CT) scans.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead
• Maastricht University Medical Center: collaborator
• Gelre Hospitals: collaborator
• Medisch Spectrum Twente: collaborator
• University Medical Center Groningen: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Amsterdam UMC: collaborator
• Maag Lever Darm Stichting: collaborator

Study Sites (6)

Universitair Ziekenhuis Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Gelre Ziekenhuizen

Apeldoorn, Gelderland, 7334DZ, Netherlands

NOT YET RECRUITING

Maastricht University Medical Centre+ (MUMC=)

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Amsterdam University Medical Centre (UMC) - Location VUMC

Amsterdam, North Holland, 1081HV, Netherlands

NOT YET RECRUITING

Amsterdam University Medical Centre (UMC) - Location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

NOT YET RECRUITING

University Medical Centre Groningen (UMCG)

Groningen, 9713GZ, Netherlands

NOT YET RECRUITING

Related Publications (1)

• Duivenvoorden AAM, Clarysse M, Ceulemans LJ, Geelkerken RH, Derikx JPM, de Vries JPM, Buscher HCJL, Olde Damink SWM, van Schooten FJ, Lubbers T, Lenaerts K; Dutch Mesenteric Ischemia Study group (DMIS). 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). BMJ Open. 2023 Aug 29;13(8):e072875. doi: 10.1136/bmjopen-2023-072875.

  PMID: 37643848 DERIVED

Related Links

• Continuous administration of enteral lipid- and protein-rich nutrition limits inflammation in a human endotoxemia model
• Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins
• Plasma intestinal fatty acid-binding protein levels correlate with morphologic epithelial intestinal damage in a human translational ischemia-reperfusion model
• Human intestinal ischemia-reperfusion-induced inflammation characterized: experiences from a new translational model
• SM22 a Plasma Biomarker for Human Transmural Intestinal Ischemia
• Acute mesenteric ischemia: a clinical review

Biospecimen

Retention: SAMPLES WITH DNA

After patient inclusion, blood and air samples will be collected at consecutive time points. Plasma will be isolated from the collected blood and analyzed by enzyme-linked immunosorbent assay (ELISA) for the selected biomarkers: I-FABP, SM22 and VIL-1. ELISAs for I-FABP, Exhaled air will be stabilized on carbon desorption tubes until analysis. The VOC profile will be analyzed by gas chromatography time of flight mass spectrometry (GC-TOF-MS) including compound separation by GC and full mass spectra recording by TOF-MS.

MeSH Terms

Conditions

Intestinal Diseases; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annet Duivenvoorden, MSc

  Maastricht University

  STUDY CHAIR

• Kaatje Lenaerts, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annet AM Duivenvoorden, MSc

CONTACT

+31433881527; annet.duivenvoorden@maastrichtuniversity.nl

Kaatje Lenaerts, PhD

CONTACT

+31433881547; kaatje.lenaerts@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: September 15, 2020
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2024
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

BE (1); NL (5)