title: Intestinal fatty acid binding protein as a marker for intra-abdominal pressure-related complications in patients admitted to the intensive care unit; study protocol for a prospective cohort study (I-Fabulous study).
abstract: BACKGROUND
  Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have detrimental effects on all organ systems and are associated with increased morbidity and mortality in critically ill patients admitted to an intensive care unit. Intra-bladder measurement of the intra-abdominal pressure (IAP) is currently the gold standard. However, IAH is not always indicative of intestinal ischemia, which is an early and rapidly developing complication. Sensitive biomarkers for intestinal ischemia are needed to be able to intervene before damage becomes irreversible. Gut wall integrity loss, including epithelial cell disruption and tight junctions breakdown, is an early event in intestinal damage. Intestinal Fatty Acid Binding Protein (I-FABP) is excreted in urine and blood specifically from damaged intestinal epithelial cells. Claudin-3 is a specific protein which is excreted in urine following disruption of intercellular tight junctions. This study aims to investigate if I-FABP and Claudin-3 can be used as a diagnostic tool for identifying patients at risk for IAP-related complications.
  
  
  METHODS
  In a multicenter, prospective cohort study 200 adult patients admitted to the intensive care unit with at least two risk factors for IAH as defined by the World Society of the Abdominal Compartment Syndrome (WSACS) will be included. Patients in whom an intra-bladder IAP measurement is contra-indicated or impossible and patients with inflammatory bowel diseases that may affect I-FABP levels will be excluded. The IAP will be measured using an intra-bladder technique. During the subsequent 72 hours, the IAP measurement will be repeated every six hours. At these time points, a urine and serum sample will be collected for measurement of I-FABP and Claudin-3 levels. Clinical outcome of patients during their stay at the intensive care unit will be monitored using the Sequential Organ Failure Assessment (SOFA) score.
  
  
  CONCLUSIONS
  Successful completion of this trial will provide evidence on the eventual role of the biomarkers I-FABP and Claudin-3 in predicting the risk of IAP-associated adverse outcome. This may aid early (surgical) intervention.
  
  
  BACKGROUND
  The trial is registered at the Netherlands Trial Register (NTR4638).
authors.forename: Steven G
authors.initials: SG
authors.lastname: Strang
authors.forename: Oscar J F
authors.initials: OJ
authors.lastname: Van Waes
authors.forename: Ben
authors.initials: B
authors.lastname: Van der Hoven
authors.forename: Samir
authors.initials: S
authors.lastname: Ali
authors.forename: Michael H J
authors.initials: MH
authors.lastname: Verhofstad
authors.forename: Peter
authors.initials: P
authors.lastname: Pickkers
authors.forename: Esther M M
authors.initials: EM
authors.lastname: Van Lieshout
mesh_terms: D034841:Abdominal Cavity / Q000503:physiopathology; D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D003161:Compartment Syndromes / Q000097:blood / Q000453:epidemiology / Q000209:etiology*; D016638:Critical Illness; D018450:Disease Progression; D050556:Fatty Acid-Binding Proteins / Q000097:blood*; D005260:Female; D006801:Humans; D015994:Incidence; D007297:Inpatients; D007362:Intensive Care Units; D059325:Intra-Abdominal Hypertension / Q000097:blood* / Q000150:complications / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011312:Pressure; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D055815:Young Adult
chemical_list: D015415:Biomarkers; D050556:Fatty Acid-Binding Proteins