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Active, Not Recruiting

NCT Number: NCT03929159

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Septicemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood biospecimen collection

Primary outcomes

  1. Change in cellular and viral micro ribonucleic acids (miRNAs)

    Time frame: Baseline up to day 1

    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.

  2. 7-day mortality rate

    Time frame: Baseline up to day 7

    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.

Secondary outcomes

  1. T and B cells immune phenotypes

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Profile of miRNA Changes in Sepsis and Surgical Trauma

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2019
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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