Septicemia Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS) |
United States,
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 |
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