ISRCTN99754654已完成未知
Analysis of geNe Expression and bioMarkers fOr poiNt-of-care dEcision support in Sepsis: a prospective observational study
Cardiff University (UK)0 个研究点目标入组 200 人开始时间: 2014年2月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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