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Intestinal Fatty Acid Binding Protein as a Marker for Increased Intra-Abdominal Pressure (I-Fabulous study)


- candidate number18199
- NTR NumberNTR4638
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2014
- Secondary IDsMEC-2011-016 
- Public TitleIntestinal Fatty Acid Binding Protein as a Marker for Increased Intra-Abdominal Pressure (I-Fabulous study)
- Scientific TitleIntestinal Fatty Acid Binding Protein as a Marker for Increased Intra-Abdominal Pressure (I-Fabulous study)
- ACRONYMI-Fabulous
- hypothesisIt is expected that the urinary and serum level of intestinal fatty acid binding protein (I-FABP) and the urinary level of Claudin-3 have prognostic relevance for early identification of patients at risk for intestinal ischemia-related morbidity or mortality
- Healt Condition(s) or Problem(s) studiedIntra-abdominal hypertension, Abdominal compartment syndrome
- Inclusion criteria1. Patients with at least two risk factors as agreed by the World Society of the Abdominal Compartment Syndrome (WSACS)
2. Age 18 or older, with no upper age limit
3. Signed informed consent by patient or proxy
- Exclusion criteria1. Patients with bladder trauma or hematuria in whom intra-bladder pressure measurement is contra-indicated
2. Patients in whom intra-bladder pressure measurements are not possible due to intraperitoneal adhesions, bladder oppressive pelvic hematoma, abdominal packs in situ, or previous bladder removal
3. Patients with inflammatory bowel disease that may affect I-FABP levels, such as Crohn's disease or ulcerative colitis
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 18-apr-2011
- planned closingdate30-jun-2015
- Target number of participants200
- InterventionsNot applicable
- Primary outcomeIntestinal Fatty Acid Binding Protein (I-FABP) level in urine
- Secondary outcomeClaudin-3 level in urine and serum
I-FABP level in serum
- TimepointsEvery six hours from 0-72 hours after enrolment
- Trial web siteNot applicable
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD O.J.F. Waes, van
- CONTACT for SCIENTIFIC QUERIESMD O.J.F. Waes, van
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- PublicationsStrang SG, Van Waes OJF, Van der Hoven B, Ali S, Verhofstad MHJ, Pickkers P, Van Lieshout EMM. 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). Scand J Trauma Resusc Emerg Med. 2015 Jan 16;23(1):6.
- Brief summaryBACKGROUND
Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have detrimental effects on all organ systems and are associated with increased morbidity and mortality rates 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, it is not always feasible of reliable. Moreover, IAH is not always indicative of intestinal ischemia, which is an early and rapidly developing complication. Sensitive biomarkers for intestinal ischemia are needed in order to be able to intervene before damage becomes irreversible. Gut wall integrity loss, including breakdown of tight junctions, is an early event in intestinal damage. Intestinal Fatty Acid Binding Protein (I-FABP) is excreted into the urine and blood by damaged intestinal epithelial cells. Claudin-3 is excreted in urine following disruption of tight junctions.

AIM
The main aim of this study is to determine the relevance of I-FABP levels in urine as diagnostic tool for identifying patients at risk for intra-abdominal pressure-related problems. Secondary aims are to evaluate the same for serum I-FABP levels, to determine if Claudin-3 levels in urine (representing tight-junction disruption) correlate with IAP or I-FABP levels, and to determine if I-FABP and Claudin-3 levels can be used as prognostic indicator for intestinal ischemia-related morbidity.

STUDY DESIGN
Multi-center observational cohort study.

POPULATION
200 patients admitted to the Intensive Care Unit. Adult patients with at least two risk factors for IAH as defined by the World Society of the Abdominal Compartment Syndrome (WSACS) are eligible for enrolment. 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.

METHOD
During the first 72 hours after enrolment, 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.

OUTCOME MEASURES
I-FABP level in urine will serve as primary outcome measure.
I-FABP level in serum and Claudin-3 level in urine and serum will serve as secondary outcome measure.
- Main changes (audit trail)
- RECORD24-jun-2014 - 5-jan-2016


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