Clinical trial NCT03929159: Correlating MicroRNA Changes With Sepsis Outcomes
Official title: Profile of miRNA Changes in Sepsis and Surgical Trauma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Septicemia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2019-04-26
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients electively scheduled for surgical operation requiring anesthesia and hospitalization of longer than 1 day, or patients with high clinical suspicion of sepsis

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cellular and viral micro ribonucleic acids (miRNAs)
timeFrame: Baseline up to day 1
measure: 7-day mortality rate
timeFrame: Baseline up to day 7
Secondary outcomes:
measure: T and B cells immune phenotypes
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sai-Ching J Yeung
role: PRINCIPAL_INVESTIGATOR
References: