ACTRN12610000465055招募中未知
Continuous Monitoring of Patients with Severe Sepsis or Septic Shock using SeptiCyte (registered trademark) Lab and Procalcitonin Comparator to Determine the Relationship Between Inflammatory Index and Clinical Progression and Outcome Measures
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Aged over 18 years
- •2.Body Mass Index < 40
- •3.Clinical signs and symptoms of severe sepsis or septic shock. In brief, patients must be admitted to the intensive care unit with two or more signs of systemic inflammation within the last 24 hours, with a proven or suspected source of infection and the sepsis-induced dysfunction of at least one organ or system. The absence of positive culture results will not affect clinical diagnosis of sepsis.
- •Systemic Inflammatory Response (SIRS) Criteria: temperature >38°C or <36°C; heart rate >90 beats/min; respiratory rate >20 breathes/min or a partial pressure of carbon dioxide (PaCO2) of <4.3 kPa (<32 mm Hg) or mechanical ventilation; and a white blood cell count <4,000 cells/mm3 (<4 x 109 cells/L) or >12,000 cells/mm3 (>12 x 109 cells/L) or >10% immature neutrophils (band forms). (Consensus from the American College of Chest Physicians/ Society of Critical Care Medicine)
- •Infection Criteria: evidence of proven or suspected infection as demonstrated by one or more of the following: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in association with the production of purulent sputum; a syndrome related to a high risk of infection
- •Organ/System Dysfunction Criteria:
- •Cardiovascular – systolic arterial blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for >1 hr, despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;
- •Pulmonary – partial pressure of arterial oxygen/inspired oxygen (PaO2/FiO2 ratio) less than or equal to 250 in the presence of other dysfunctional organs or systems or less than or equal to 200 if the lung is the only dysfunctional organ;
- •Renal – urine output of <0.5 ml/kg of body weight/ hr for 1 hour, despite adequate fluid resuscitation;
- •Unexplained Metabolic Acidosis – pH less than or equal to 7.30 or a base deficit of greater than or equal to 5.0 mmol/L in association with a plasma lactate level that is >1.5 times the upper limit of the local laboratory reference range
- •Haematologic – platelet count <80,000/mm3 (<80,000 microlitres), or platelet count has decreased by 50% in the 3 days preceding enrolment.
- •4. The patient and substitute health authority are fluent in English (both written and spoken) and the patient or substitute health authority are capable of providing informed consent to participate in the study
排除标准
- •1. Patients who have an autoimmune disease or other documented chronic immunological disorder e.g. systemic lupus erythmatosus (SLE), Crohn’s disease, rheumatoid arthritis, multiple sclerosis (MS), Type 1 Diabetes Mellitus
- •2. Oncology patients receiving chemotherapy within the last 3 months
- •3. Solid-organ transplant recipients
研究者
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