Correlating MicroRNA Changes With Sepsis Outcomes

Recruiting

• Conditions: Septicemia

• Registration Number: NCT03929159
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-4-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Inclusion Criteria:<br><br> - Electively scheduled for surgical operation that require general anesthesia and<br> expected duration of hospitalization of longer than one day (for patients in<br> Perioperative Evaluation & Management [POEM]) or high clinical suspicion of sepsis<br> by the emergency physician (for patients in emergency center)<br><br> - Ability to give informed consent. If the patient is incapacitated and unable to give<br> informed consent, the next-of-kin or a person who has the power of attorney must be<br> present for informed consent.<br><br> - For patients in the emergency center only, two or more of the following SIRS<br> criteria:<br><br> - Leukocytes > 12,000/mm^3 or < 4,000/mm^3 or > 10% immature (band) forms,<br> provided that no filgrastim or pegfilgrastim was administered within 30 days<br> and no leukemia<br><br> - Heart rate > 90 beats/minute (min)<br><br> - Respiratory rate > 20 breaths/min or partial pressure of carbon dioxide (CO2) <<br> 32 mmHg<br><br> - Oral temperature > 38 degrees Celsius (C) or < 36 degrees C or axillary<br> temperature > 37 degrees C or < 35 degrees C<br><br>Exclusion Criteria:<br><br> - Inability to give informed consent or a person who has power of attorney for medical<br> decision is not available<br><br> - Being moribund (for patients in emergency center) or cancellation of surgery (for<br> patients in POEM)<br><br> - Active Do Not Resuscitate or Do Not Intubate order

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cellular and viral micro ribonucleic acids (miRNAs);7-day mortality rate

Secondary Outcome Measures

Name	Time	Method
T and B cells immune phenotypes