STUDY00015328: Sepsis Endotypes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-06

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis

Patients with sepsis as defined by the Sepsis-3 criteria

No interventions assigned to this group

Control

Patients without sepsis, as defined by the Sepsis-3 criteria

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adults (age ≥ 18 )
2. gender: male or female
3. 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
4. Clinical suspicion for sepsis (except for control/comparison group for whom infection is NOT a current concern)

Exclusion Criteria

1. Patients with hematologic malignancies
2. Pregnant women
3. Patient/surrogate is not fluent in English and no translation services are available
4. Long-term immunosuppressive therapy
5. Prisoner

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No