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NCT Number: NCT03146546

STUDY00015328: Sepsis Endotypes

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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
  • Prisoner

Treatment and study plan

Primary outcomes

  1. 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

  1. The expression of BPGM and AP2 transcripts

    Time frame: 5 years for completion of study, 1 year follow up per patient enrolled

    sepsis-associated gene pathways

  2. Clinical variables

    Time frame: 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.

  3. Acute Physiology and Chronic Health Evaluation II Score

    Time frame: 5 years for completion of study, 1 year follow up per patient enrolled

    scale 0-71, with higher scores being worse

  4. Sequential Organ Failure Assessment

    Time frame: 5 years for completion of study, 1 year follow up per patient enrolled

    scale of 0-24, with higher scores being worse score

  5. Muscle measurements

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Diagnostic and Prognostic Biomarkers to Elucidate Sepsis Endotypes

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 10, 2017
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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