Correlating MicroRNA Changes With Sepsis Outcomes
Correlating MicroRNA Changes With Sepsis Outcomes
This trial studies how changes in microRNAs may correlate with sepsis outcomes. Sepsis is a
 type of severe infection of the blood stream, and its diagnosis may be obscured by many other
 conditions such as surgery, trauma, and cancer. MicroRNAs are biomarkers found in the blood
 and tissue. Blood samples may help correlate changes in microRNA expression to patient
 reactions to a sepsis infection.
PRIMARY OBJECTIVES:

 I. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma
 and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of
 sepsis.

 SECONDARY OBJECTIVES:

 I. To distinguish systemic inflammatory response syndrome (SIRS) without infection from
 sepsis and septic shock.

 OUTLINE: Patients are assigned to 1 of 2 groups.

 GROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day
 after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6
 days after the baseline blood draw if still hospitalized.

 GROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis),
 the day after baseline, and on day 7 from baseline if still hospitalized.
Inclusion Criteria:

 -  Electively scheduled for surgical operation that require general anesthesia and
 expected duration of hospitalization of longer than one day (for patients in
 Perioperative Evaluation & Management [POEM]) or high clinical suspicion of sepsis by
 the emergency physician (for patients in emergency center)

 -  Ability to give informed consent. If the patient is incapacitated and unable to give
 informed consent, the next-of-kin or a person who has the power of attorney must be
 present for informed consent.

 -  For patients in the emergency center only, two or more of the following SIRS criteria:

 -  Leukocytes > 12,000/mm^3 or < 4,000/mm^3 or > 10% immature (band) forms, provided
 that no filgrastim or pegfilgrastim was administered within 30 days and no
 leukemia

 -  Heart rate > 90 beats/minute (min)

 -  Respiratory rate > 20 breaths/min or partial pressure of carbon dioxide (CO2) <
 32 mmHg

 -  Oral temperature > 38 degrees Celsius (C) or < 36 degrees C or axillary
 temperature > 37 degrees C or < 35 degrees C

 Exclusion Criteria:

 -  Inability to give informed consent or a person who has power of attorney for medical
 decision is not available

 -  Being moribund (for patients in emergency center) or cancellation of surgery (for
 patients in POEM)

 -  Active "Do Not Resuscitate" or "Do Not Intubate" order