Plasma i-FABP as Predictor for Irreversible Bowel Ischemia (FARAMIS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Mesenteric Ischemia; Bowel Necrosis

Detailed 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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • Recruiting
    • University Hospital Regensburg
    • Contact: Philipp Renner, MD; Phone Number: +49 151 1944 5787; Email: philipp.renner@ukr.de
    • Contact: Peter Heiss, MD; Phone Number: +49 941 944 7401; Email: peter.heiss@ukr.de
    • Principal Investigator: Peter Heiss, MD, MS
    • Sub-Investigator: Philipp Renner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tertiary care clinic

Description

Inclusion Criteria:

• Presence of acute mesenteric ischemia due to stenosis of the superior mesenteric artery, thromboembolization of the superior mesenteric artery, non-occlusive mesenteric ischemia or acute portal vein thrombosis (as confirmed by CT scan)
• The vascular anatomy is suitable for percutaneous revascularization
• A primary endovascular re-vascularisation approach is intended based on an interdisciplinary decision by the visceral surgeon, the vascular surgeon and interventional radiologist. This therapeutic decision is made independently of the proposed FARAMIS study.
• A peripheral or central line is present to perform repeated blood collections

Exclusion Criteria:

• Clinically or imaging results indicating that perforation of the bowel is present or suspected
• Hemodynamic instability (shock)
• Pre-existing severe liver or kidney damage (defined as spontaneous international normalized ratio >2 or creatinine >2 mg/dl.)
• Anemia with hemoglobin concentration < 7g/dl
• Pediatric patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with acute mesenteric ischemia; Patients with acute mesenteric ischemia meeting the in-/exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-interventional course of plasmatic i-FABP as reliable predictor for successful bowel revascularization	Subjects will be observed for 72 hours after percutaneous revascularization. Patients will then be divided into two groups: patients not requiring surgery and not dying from intestinal necrosis will be allocated to group A. Subjects who undergo surgery without signs of necrotic segments will also be attributed to group A. Patients in whom intestinal necrosis is confirmed by surgery or autopsy will belong to group B. 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. ROC-analysis will be carried out and the area under the curve will be determined for different R-values.	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Baseline level of i-FABP as predictor of bowel necrosis	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of i-FABP, interleukine 6 and 8	Association of increased levels of i-FABP, interleukine 6 and 8 with extension of intestinal necrosis according to the pathology report and occurrence of organ failure	72 hours

Collaborators and Investigators

• Sponsor: University Hospital Regensburg
• Collaborators: William Cook Europe
• Investigators: Principal Investigator: Peter Heiss, MD, MS, University Hospital Regensburg Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Acute mesenteric ischemia; Percutaneous endovascular revascularization; Intestinal plasma fatty acid binding protein (i-FABP); Bowel necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ischemia; Necrosis; Mesenteric Ischemia
• Other Study ID Numbers: FARAMIS 2013