Correlating MicroRNA Changes With Sepsis Outcomes

N/AActive Not RecruitingNCT03929159

M.D. Anderson Cancer Center150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Septicemia

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood biospecimen collection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in cellular and viral micro ribonucleic acids (miRNAs)

For each of the cellular and viral miRNAs, samples from patients with sepsis versus (vs.) patients with systemic inflammatory response syndrome (SIRS) without sepsis vs. patients presenting for pre-op evaluation (reference group without SIRS or sepsis) will be compared by one-way analysis of variance. Will compare the miRNA expression intergroup differences.

Time frame: Baseline up to day 1

7-day mortality rate

Will be correlated with miRNA changes. Will compare the changes of the miRNAs from baseline to day 1 between the patients who were still alive 7 days after diagnosis of sepsis and those who died within 7 days of sepsis diagnosis.

Time frame: Baseline up to day 7

Secondary Outcomes

T and B cells immune phenotypes

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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