Correlating MicroRNA Changes With Sepsis Outcomes

Profile of miRNA Changes in Sepsis and Surgical Trauma

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.

Study Overview

• Status: Recruiting
• Conditions: Septicemia
• Intervention / Treatment: Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: Sai-Ching J. Yeung; Phone Number: 713-745-9911; Email: syeung@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Sai-Ching J. Yeung; Phone Number: 713-745-9911
      • Principal Investigator: Sai-Ching J. Yeung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A (biospecimen collection); 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.	Procedure: Biospecimen Collection; Undergo blood biospecimen collection
Group B (biospecimen collection); Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.	Procedure: Biospecimen Collection; Undergo blood biospecimen collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline up to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
T and B cells immune phenotypes	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Sai-Ching J Yeung, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: 2018-0757 (Other Identifier: M D Anderson Cancer Center); NCI-2019-00833 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01GM122775 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No