Diagnostic and Prognostic Biomarkers to Elucidate Sepsis Endotypes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- death and chronic critical illness
- Status
- Enrolling By Invitation
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Anthony Bonavia
Professor
Penn State Health Milton S Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •Adults (age ≥ 18 )
- •gender: male or female
- •Cognitively intact or impaired patients, given that sepsis may cause a certain degree of cognitive dysfunction in patients. All patients in the control group (no sepsis) will be cognitively intact
- •Clinical suspicion for sepsis (except for control/comparison group for whom infection is NOT a current concern)
Exclusion Criteria
- •Patients with hematologic malignancies
- •Pregnant women
- •Patient/surrogate is not fluent in English and no translation services are available
- •Long-term immunosuppressive therapy
Outcomes
Primary Outcomes
death and chronic critical illness
Time Frame: 5 years for completion of study, 1 year follow up per patient enrolled
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.
Secondary Outcomes
- Sequential Organ Failure Assessment(5 years for completion of study, 1 year follow up per patient enrolled)
- The expression of BPGM and AP2 transcripts(5 years for completion of study, 1 year follow up per patient enrolled)
- Muscle measurements(5 years for completion of study, 1 year follow up per patient enrolled)
- Clinical variables(5 years for completion of study, 1 year follow up per patient enrolled)
- Acute Physiology and Chronic Health Evaluation II Score(5 years for completion of study, 1 year follow up per patient enrolled)