Plasma i-FABP as Predictor for Irreversible Bowel Ischemia — FARAMIS  

Acute Mesenteric Ischemia Clinical Trial

Official title: Plasma i-FABP as Predictor for Irreversible Bowel Ischemia After Interventional Re-vascularization in Patients With Acute Mesenteric Ischemia

Status Recruiting

Clinical Trial Summary

In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI) undergoing primary percutaneous angiographic intervention.

The investigators postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FABP within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not.

If true, patients requiring laparotomy and bowel resection could be identified and patients in whom angiographic intervention led to successful cure of disease would not be exposed to potentially perilous surgery.

Clinical Trial Description

Intestinal plasma fatty acid binding proteins (i-FABP) have been introduced as a powerful marker for the diagnosis of intestinal ischemia. Based on several small studies, this marker is referred to as a sensitive indicator for intestinal ischemia. I-FABP is characterized by its short half-time of eleven minutes in blood circulation, which might allow "real-time" monitoring of necrotic intestinal segments.

Subjects meeting the in-/exclusion criteria will undergo five to six blood collections: one baseline assessment before revascularization, three assessments directly after angiographic intervention (5/30/120 minutes), and one assessment after 24 hours. An additional blood collection will be performed in patients who underwent subsequent surgery. In addition, clinical exams of the patient are carried out.

Subjects will be observed for 72 hours after percutaneous revascularization and retrospectively classified depending on the clinical course: recovering patients or patients undergoing surgery without signs of necrotic segments will be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B. For all patients, clinical and laboratory findings will be reported in a descriptive manner.

To evaluate whether the post-interventional course of plasmatic i-FABP is a reliable predictor for successful revascularization, the minimum level of i-FABP at the time points 5, 30 and 120 Minutes is divided by the baseline (= before intervention) level of i-FABP. This ratio (R) reflects the decrease (or increase) of i-FABP after revascularization. Receiver operating characteristic (ROC)-analysis will be carried out and the area under the curve will be determined for different R-values (e.g. 0.3, 0.5, 0.7).

We postulate that patients with fully re-established intestinal blood flow and vital intestines will display a significant drop of plasmatic i-FAPB within 24 hours, while patients requiring subsequent intestinal resection due to irreversible bowel necrosis will not. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Mesenteric Ischemia
• Bowel Necrosis
• Ischemia
• Necrosis

• NCT number: NCT01788904
• Study type: Observational
• Source: University Hospital Regensburg
• Contact: Peter G Heiss, MD, MS
• Phone: +49 941 944 7401
• Email: peter.heiss@ukr.de
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Completion date: June 2017