It 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…
Bron
Verkorte titel
Aandoening
Intra-abdominal hypertension and abdominal compartment syndrome
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Intestinal Fatty Acid Binding Protein (I-FABP) level in urine
Achtergrond van het onderzoek
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 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.
Doel van het onderzoek
It 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
Onderzoeksopzet
Every six hours from 0-72 hours after enrolment
Onderzoeksproduct en/of interventie
Not applicable
Publiek
Mailbox H-822k <br>
P.O. Box 2040, 3000 CA Rotterdam
O.J.F. Waes, van
's-Gravendijkwal 230, 3015 CE Rotterdam
Rotterdam
The Netherlands
+31-10 7031050
o.vanwaes@erasmusmc.nl
Wetenschappelijk
Mailbox H-822k <br>
P.O. Box 2040, 3000 CA Rotterdam
O.J.F. Waes, van
's-Gravendijkwal 230, 3015 CE Rotterdam
Rotterdam
The Netherlands
+31-10 7031050
o.vanwaes@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4134 |
NTR-old | NTR4638 |
Ander register | : MEC-2011-016 |