Analysis of geNe Expression and bioMarkers fOr poiNt-of-care dEcision support in Sepsis

Not Applicable

Completed

• Conditions: Sepsis, SIRS without infection; Infections and Infestations

• Registration Number: ISRCTN99754654
• Lead Sponsor: Cardiff University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-28
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.
3. Severe sepsis is defined as sepsis plus at least one organ failure, except when that organ failure was already present 48 hours before the onset of sepsis.
4. Organ failure is defined as a Sequential Organ Failure Assessment (SOFA) score > 2 for the organ in question
5. Presenting to hospital with abdominal or pulmonary sepsis of less than 72 hours duration
6. Patient already has or will require arterial cannulation as part of standard treatment

Inclusion criteria for critically ill patients without infection:
1. Patients admitted to the ICU following out-of hospital cardiac arrest
2. SIRS criteria as above
3. Organ failure criteria as above
4. Patients must not be receiving antibiotics for treatment of known or suspected infection
5. Patient already has or will require arterial cannulation as part of standard treatment

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

Study & Design

• Study Type: Observational
• Study Design: Not specified