Analysis of geNe Expression and bioMarkers fOr poiNt-of-care dEcision support in Sepsis: a prospective observational study

Cardiff University (UK)0 sites200 target enrollmentFebruary 28, 2014

ConditionsSepsis, SIRS without infection Infections and Infestations

Overview

Phase: 未知
Intervention: Not specified
Conditions: Sepsis, SIRS without infection
Sponsor: Cardiff University (UK)
Enrollment: 200
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 28, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cardiff University (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Aged 16 years or over
•2\. Diagnosis of severe sepsis. Sepsis is defined as:
•2\.1\. A defined focus of infection: indicated by either:
•2\.1\.1\. An organism grown in blood or sterile site OR
•2\.1\.2\. An abscess or infected tissue (e.g., pneumonia, peritonitis, urinary tract, vascular line infection, soft tissue, etc)
•2\.2\. At least two systemic inflammatory response syndrome (SIRS) criteria. The four SIRS criteria are:
•2\.2\.1\. Core temperature \>38°C or \<36°C (core temperature is rectal, urinary bladder, central line, or tympanic). If oral, inguinal or axillary temperatures are used, add 0\.5°C to the measured value. Hypothermia \<36°C must be confirmed by core temperature only. Use the most deranged value recorded in the 24 hours before ICU admission.
•2\.2\.2\. Heart rate \>90 beats/minute. If patient had an atrial arrhythmia, record the ventricular rate. If patients have a known medical condition or are receiving treatment that would prevent tachycardia (for example, heart block or beta blockers), they must meet two of the remaining three SIRS criteria. Use the most deranged value recorded in the 24 hours before ICU admission.
•2\.2\.3\. Respiratory rate \> 20 breaths per minute or a PaCO2 \< 4\.3 kPa (32 mmHg) or mechanical ventilation for an acute process. Use the most deranged respiratory rate or PaCO2 recorded in the 24 hours before ICU admission.
•2\.2\.4\. White blood cell count of \>12 x 109/l or \< 4 x 109/l or \> 10% immature neutrophils (band forms). Use the most deranged value recorded in the 24 hours before ICU admission.

Exclusion Criteria

•1\. Age less than 16 years
•2\. Pregnant
•3\. Severe immune deficiency, for example a diagnosis of AIDS
•4\. Anti\-rejection transplant drugs
•5\. Methotrexate
•6\. High\-dose corticosteriod treatment (\>10 mg prednisolone/day or equivalent)
•7\. Severe liver failure
•8\. Childs III or worse