STUDY00015328: Sepsis Endotypes
- Conditions
- Sepsis
- Registration Number
- NCT03146546
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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)
- Patients with hematologic malignancies
- Pregnant women
- Patient/surrogate is not fluent in English and no translation services are available
- Long-term immunosuppressive therapy
- Prisoner
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method death and chronic critical illness 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 Outcome Measures
Name Time Method Sequential Organ Failure Assessment 5 years for completion of study, 1 year follow up per patient enrolled scale of 0-24, with higher scores being worse score
The expression of BPGM and AP2 transcripts 5 years for completion of study, 1 year follow up per patient enrolled sepsis-associated gene pathways
Muscle measurements 5 years for completion of study, 1 year follow up per patient enrolled Clinical measurement of quadriceps depth (ultrasound) and skeletal muscle area (on existing CT scan)
Clinical variables 5 years for completion of study, 1 year follow up per patient enrolled 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.
Acute Physiology and Chronic Health Evaluation II Score 5 years for completion of study, 1 year follow up per patient enrolled scale 0-71, with higher scores being worse
Trial Locations
- Locations (1)
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States