Correlating MicroRNA Changes With Sepsis Outcomes

NCT03929159 | Active Not Recruiting

• 3 other identifiers: 2018-0757NCI-2019-00833R01GM122775
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Septicemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• T and B cells immune phenotypes

  Up to 2 years

Study Arms (2)

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

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood biospecimen collection

Group A (biospecimen collection); Group B (biospecimen collection)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Sai-Ching J Yeung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: March 26, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)