Correlating MicroRNA Changes With Sepsis Outcomes

Septicemia Clinical Trial

Official title:

Profile of miRNA Changes in Sepsis and Surgical Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929159
• Other study ID #: 2018-0757
• Secondary ID: NCI-2019-0083320
• Status: Recruiting
• Start date: March 26, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sai-Ching J. Yeung
• Phone: 713-745-9911
• Email: syeung[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septicemia

Intervention

Procedure:
• Biospecimen Collection
Undergo blood biospecimen collection

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	T and B cells immune phenotypes		Up to 2 years

External Links

•   MD Anderson Cancer Center Website