Development of a new strategy to predict early sepsis

Development of a new strategy to predict early sepsis - Sepsis Transcriptome

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46603

Enrollment

100

Registered

2018-06-26

Start date

2018-08-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis blood infection/poisoning sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Study subjects (sepsis): * Presenting to the Emergency Department (ED) * Attending physician suspect sepsis based on at least 2 sign of SIRS criteria and suspicion of infection * 19 years of age or greater;Surgical Subjects (control group): * Having surgery * 19 years of age or greater * Subjects already undergoing blood collection during their hospital stay * Non*emergency surgery subjects including ear/nose and throat cases, orthopedic surgery of the major joints including hip, knee, ankle, shoulder, and wrist.

Exclusion criteria

Exclusion criteria: * Patient is terminal (death anticipated in 12 hours) * Subjects who are unable to obtain blood as a standard of care. * Blood sample could not be taken within 24 hours of a physician first contact in the ED with the patient.

Design outcomes

Primary

Measure	Time frame
Molecular analysis - CR gene expression (RNA) signature (e.g. measured by RNA sequencing and qPCR) Disease severity - Physician Diagnosis of sepsis - Biomarkers of disease severity - Presumed source of infection - Treatment parameters - Vital signs at presentation, and after 3 hours - Clinical impression score at presentation, and after 3 hours - MEDS score at presentation, and after 3 hours - SOFA score at presentation, and after 3 hours - APACHE-II score at presentation, and after 3 hours - PIRO score at presentation, and after 3 hours - Organ Failure Free Days - Admittance to the ICU - Length of stay at ICU - Length of hospital stay - Progression to septic shock (i.e. persistent hypotension despite adequate fluid resuscitation) - In-hospital mortality - 28-day mortality Demographic parameters, medication use, co-morbidity and functional status - Demographic characteristics (i.e. age, sex) - Smoking - Known pregnancy - Co-morbidity: Charlson comorbidity index - Functional status: Barthel Index and WHO performance index - Medication use	—

Measure

Time frame

Molecular analysis - CR gene expression (RNA) signature (e.g. measured by RNA sequencing and qPCR) Disease severity - Physician Diagnosis of sepsis - Biomarkers of disease severity - Presumed source of infection - Treatment parameters - Vital signs at presentation, and after 3 hours - Clinical impression score at presentation, and after 3 hours - MEDS score at presentation, and after 3 hours - SOFA score at presentation, and after 3 hours - APACHE-II score at presentation, and after 3 hours - PIRO score at presentation, and after 3 hours - Organ Failure Free Days - Admittance to the ICU - Length of stay at ICU - Length of hospital stay - Progression to septic shock (i.e. persistent hypotension despite adequate fluid resuscitation) - In-hospital mortality - 28-day mortality Demographic parameters, medication use, co-morbidity and functional status - Demographic characteristics (i.e. age, sex) - Smoking - Known pregnancy - Co-morbidity: Charlson comorbidity index - Functional status: Barthel Index and WHO performance index - Medication use

—

Secondary

Measure	Time frame
Molecular analysis: - Genome analysis (e.g. measured by DNA sequencing, and PCR) - Proteome analysis (e.g. measured by Olink proteomics and, ELISA)	—

Countries

Netherlands

Outcome results