An observational study in Sepsis, sponsored by Milton S. Hershey Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Milton S. Hershey Medical Center · Observational
Determine the utility of biomarkers measured in blood and body fluid (stool, saliva, tracheal aspirate) when combined with clinical data, for predicting sepsis phenotypes that are associated with poor clinical outcomes. We hypothesize that resistin is a biomarker which provides critical prognostic information when used in conjunction with standard clinical data, in patients with sepsis and septic shock.
Day 1 Sample Collection: 20ml of blood for chemical and genetic biomarker analysis. ≤1ml of saliva, stool, and tracheal aspirate for inflammatory marker analysis. Quadratus lumborum muscle size measurement and CT abdomen correlation. If not part of routine care, additional blood tests for cell differential, procalcitonin, and inflammatory markers.
Electronic Medical Records (EMR) Data: APACHE II and SOFA severity scores. Demographics, vital signs, inflammatory markers, organ dysfunction markers, and various blood chemistry values.
Days 2-3 Daily Documentation: Record the most abnormal value for the same parameters as Day 1.
Days 3-5 (Once) Sample Collection: Repeat of blood, saliva, stool, and tracheal aspirate collection. EMR data access for severity scores and other clinical parameters.
Days 5-6 Daily Documentation: Continued recording of the most abnormal values for clinical parameters.
Days 7-10 (Once) Sample Collection: Repeat of blood, saliva, stool, and tracheal aspirate collection. Measurement of muscle size and CT correlation. EMR data access for the same parameters as earlier.
Day 14 (or Discharge) Final Sample Collection: 20ml of blood and other samples, with no more than 1 ml/kg of blood collected over the entire study.
EMR and Clinical Data: Collection of severity scores, vital signs, inflammation markers, organ dysfunction markers, and other clinical variables.
Day 30, 3 Months, 6 Months, and 1 Year Long-term Outcomes: EMR review for clinical outcomes such as date of death, re-hospitalization, persistent critical illness. Phone interviews to gather subjective data about the post-hospitalization course and complications.
Patients in the intensive care unit (ICU) who meet critera for sepsis, as defined by the Sepsis-3 criteria and who are not excluded by any of the exclusion factors listed in the "Eligibility Criteria".
Exclusion Criteria:
Patients with sepsis as defined by the Sepsis-3 criteria
Patients without sepsis, as defined by the Sepsis-3 criteria
death and chronic critical illness
The primary outcome is a composite binary variable consisting of early death and chronic critical illness which we will determine on or before day 14 after sepsis onset.
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
The expression of BPGM and AP2 transcripts
sepsis-associated gene pathways
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
Clinical variables
including demographic variables (eg, age, sex, Elixhauser comorbidities), vital signs (eg, heart rate, respiratory rate, Glasgow Coma Scale score, systolic blood pressure, temperature, and oxygen saturation), markers of inflammation (eg, white blood cell count, premature neutrophil count \[also called bands\], erythrocyte sedimentation rate, and C-reactive protein), markers of organ dysfunction or injury (eg, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, international normalized ratio, partial pressure of oxygen, platelets, and troponin), and serum levels of glucose, sodium, hemoglobin, chloride, bicarbonate, lactate, and albumin.
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
Acute Physiology and Chronic Health Evaluation II Score
scale 0-71, with higher scores being worse
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
Sequential Organ Failure Assessment
scale of 0-24, with higher scores being worse score
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
Muscle measurements
Clinical measurement of quadriceps depth (ultrasound) and skeletal muscle area (on existing CT scan)
Time frame: 5 years for completion of study, 1 year follow up per patient enrolled
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Milton S. Hershey Medical Center