Plasma i-FABP as Predictor for Irreversible Bowel Ischemia

NCT01788904 | Unknown

• 1 other identifier: FARAMIS 2013
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Mesenteric Ischemia; Bowel Necrosis

Keywords

Acute mesenteric ischemia; Percutaneous endovascular revascularization; Intestinal plasma fatty acid binding protein (i-FABP); Bowel necrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Baseline level of i-FABP as predictor of bowel necrosis

  72 hours

Other Outcomes (1)

• Levels of i-FABP, interleukine 6 and 8

  72 hours

Study Arms (1)

Patients with acute mesenteric ischemia

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Regensburg: lead
• William Cook Europe: collaborator

Study Sites (1)

University Hospital Regensburg

Regensburg, 93053, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma, blood serum, EDTA blood

Study Officials

• Peter Heiss, MD, MS

  University Hospital Regensburg Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter G Heiss, MD, MS

CONTACT

+49 941 944 7401; peter.heiss@ukr.de

Philipp Renner, MD

CONTACT

+49 151 1944 5787; philipp.renner@ukr.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peter Heiss, MD, MS

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

DE (1)