NCT03929159

Correlating MicroRNA Changes With Sepsis Outcomes

Profile of miRNA Changes in Sepsis and Surgical Trauma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Septicemia

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood biospecimen collection

Timeline

• Start date: 2019-03-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-04-26
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States