Research Study: Search for Novel Methods to Detect Bowel Ischemia and Diagnose Acute
Abdominal Complaints
(IRB#:040704)
Principal Investigator:
Danielle Davison, M.D.
900 23rd Street, NW
Room G-105
Washington DC, 20037
202-715-4570
Sub-Investigators:
Khashayar Vaziri, M.D.
Juliet Lee, M.D.
Ray Lucas, MD
Katrina Hawkins, MD
Sponsor:
Department of Anesthesiology and Critical Care Medicine
Research Coordinator (Contact Person): Christina Seneff, CRC
Revised 06/23/15
IRB#:040704
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I.
Specific Aims
To attempt to discover novel biomarkers of intestinal inflammation and/or ischemia.
Patients with abdominal complaints, including those with appendicitis or suspected bowel
inflammation/ischemia, are usually diagnosed with a combination of clinical history,
physical exam, laboratory studies, and radiographic evaluation. Currently, there are no
biomarkers that can help diagnose bowel injury (a troponin for the bowel).
II.
Methods/Procedures
Patients who are evaluated for abdominal pain, including including acute appendicitis,
necrotizing enterocolitis, mesenteric arterial and venous occlusion, strangulated hernia,
bowel obstruction and infarcted bowel will be asked to participate in the study. In
addition, two groups of control patients will also be asked to participate in the study:
1. Surgical controls - patients undergoing elective, non-intestinal surgery, such as hernia
repair; and
2. Non-surgical/infectious controls - patients being treated for pneumonia or upper
respiratory infection (URI).
If the patient agrees, three teaspoons of blood and two tablespoons of urine (if urine
available) will be collected at that time.
Study team will recruit up to 400 patients at The George Washington University Hospital.
Patients will be enrolled with the knowledge of their surgical attending.
The relevant endpoints for the study are evidence of inflammatory or ischemic bowel by
either gross evaluation during the operative procedure or evidence of bowel
inflammation/ischemia on pathologic evaluation.
Inclusion Criteria:
(1) Patients who are being evaluated for acute abdominal pain, including appendicitis or
suspected bowel inflammation and/or ischemia
(2) Patients undergoing elective non-intestinal surgery, such as hernia repair.
(3) Patients being treated for pneumonia and/or upper respiratory infection.
(4) Males and females of at least 18 years of age able to provide informed consent.
Exclusion Criteria:
(1) Patients who are moribund or who cannot tolerate a surgical intervention
(2) Pregnant patients
(3) Patients under the age of 18.
Blood and urine samples (if urine available) obtained from the patients will be aliquoted
and then labeled with a unique code. All specimens will be stored in a -80 freezer in Ross
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Hall. None of the samples will contain PHI on their label. The key for the coded samples
will reside in Dr.Davison’s locked office.
Blood and urine samples will be analyzed for changes in proteins and RNA expression
for possible biomarker development. Research data and samples will be destroyed after
all biomarker analysis is completed and within a maximum of five years.
III.
Previous Work
There are no validated biomarkers for inflammatory or ischemic bowel in clinical use to
date.
IV.
Risks and Benefits
There are minimal risks to the patient. The risks are exclusively based on the blood draw.
The potential risk of breach of confidentiality will be minimized by coding study data and
samples with a numeric identifier. The key linking subject number to patient name will be
kept securely in the locked departmental research office.
V.
Financial Considerations
The Department of Anesthesiology and Critical Care Medicine will fund all labor and lab
tests.
There is no financial impact for the investigators. There is no financial incentive for the
patients
There will be no increase in cost for the hospital or the patient as a result of participation
in this study.
IRB#:040704
revised 06/23/15
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