Correlating MicroRNA Changes With Sepsis Outcomes

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Septicemia

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03929159

2018-0757 (Other Identifier)

R01GM122775 (U.S. NIH Grant/Contract)

NCI-2019-00833 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Group A (biospecimen collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Group B (biospecimen collection)

Description:

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

Treatment:

Procedure: Biospecimen Collection