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BMJ Open

Title:		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)
Author(s):		Duivenvoorden AAM; Clarysse M; Ceulemans LJ; Geelkerken RH; Derikx JPM; de Vries JPM; Buscher H; Olde Damink SWM; van Schooten FJ; Lubbers T; Lenaerts K; Dutch Mesenteric Ischemia Study g;
Address:		"Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands. Abdominal Transplant Laboratory, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium. Department of Abdominal Transplant Surgery and Transplant Coordination, University Hospitals Leuven, Leuven, Belgium. Leuven Intestinal Failure and Transplantation Center (LIFT), University Hospitals Leuven, Leuven, Belgium. Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Thoracic Surgery, University Hospitals Leuven, Leuven, Belgium. Department of Vascular Surgery, Medisch Spectrum Twente, Enschede, The Netherlands. Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, The Netherlands. Department of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC Location AMC, Amsterdam, The Netherlands. Department of Surgery, Division of Vascular Surgery, University of Groningen, Groningen, The Netherlands. Department of Surgery, Gelre Ziekenhuizen, Apeldoorn, The Netherlands. Department of General, Visceral and Transplantation Surgery, University Hospital RWTH Aachen, Aachen, Germany. Department of Pharmacology and Toxicology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands. Department of Surgery, GROW School for Oncology and Reproduction, Maastricht University Medical Centre+, Maastricht, The Netherlands. Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands kaatje.lenaerts@maastrichtuniversity.nl"
Journal Title:		BMJ Open
Year:		2023
Volume:		20230829
Issue:		8
Page Number:		e072875 -
DOI:		10.1136/bmjopen-2023-072875
ISSN/ISBN:		2044-6055 (Electronic) 2044-6055 (Linking)
Abstract:		"INTRODUCTION: Acute mesenteric ischaemia (AMI) is a life-threatening condition with short-term mortality of up to 80%. The diagnosis of AMI has remained troublesome due to the non-specific clinical presentation, symptoms and laboratory findings. Early unambiguous diagnosis of AMI is critical to prevent progression from reversible to irreversible transmural intestinal damage, thereby decreasing morbidity and improving survival. The present study aims to validate a panel of plasma biomarkers and investigate volatile organic compound (VOC) profiles in exhaled air as a tool to timely and accurately diagnose AMI. METHODS AND ANALYSIS: In this international multicentre prospective observational study, 120 patients (>18 years of age) will be recruited with clinical suspicion of AMI. Clinical suspicion is based on: (1) clinical manifestation, (2) physical examination, (3) laboratory measurements and (4) the physician's consideration to perform a CT scan. The patient's characteristics, repetitive blood samples and exhaled air will be prospectively collected. Plasma levels of mucosal damage markers intestinal fatty acid-binding protein and villin-1, as well as transmural damage marker smooth muscle protein 22-alpha, will be assessed by ELISA. Analysis of VOCs in exhaled air will be performed by gas chromatography time-of-flight mass spectrometry. Diagnosis of AMI will be based on CT, endovascular and surgical reports, clinical findings, and (if applicable) verified by histopathological examination. ETHICS AND DISSEMINATION: The study protocol was approved by the Medical Research Ethics Committee (METC) of Maastricht University Medical Centre+ and Maastricht University (METC azM/UM), the Netherlands (METC19-010) and the Ethics Committee Research UZ/KU Leuven, Belgium (S63500). Executive boards and local METCs of other Dutch participating centres Gelre Ziekenhuizen (Apeldoorn), Medisch Spectrum Twente (Enschede), and University Medical Centre Groningen have granted permission to carry out this study. Study results will be disseminated via open-access peer-reviewed scientific journals and national/international conferences. TRIAL REGISTRATION NUMBER: NCT05194527"
Keywords:		"Humans *Mesenteric Ischemia/diagnosis *Volatile Organic Compounds Academic Medical Centers Biomarkers Ethics Committees, Research Observational Studies as Topic Multicenter Studies as Topic Gastroenterology Intensive & critical care Surgery;"
Notes:		"MedlineDuivenvoorden, Annet A M Clarysse, Mathias Ceulemans, Laurens J Geelkerken, Robert H Derikx, Joep P M de Vries, Jean-Paul P M Buscher, Hessel C J L Olde Damink, Steven W M van Schooten, Frederik Jan Lubbers, Tim Lenaerts, Kaatje (DMIS) eng Research Support, Non-U.S. Gov't England 2023/08/30 BMJ Open. 2023 Aug 29; 13(8):e072875. doi: 10.1136/bmjopen-2023-072875"