ACTRN12606000285550尚未招募4 期
The pharmacodynamics of unfractionated heparin and fondaparinux in critically ill patients with severe sepsis.
Dr M Robertson0 个研究点目标入组 15 人开始时间: 2006年7月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Known or suspected severe sepsis at the time of screening and meet the inclusion criteria within the following 24 hours. 2. Diagnosis of severe sepsis, as defined in the recent Australian New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) study of the incidence of severe sepsis in Australian and New Zealand ICUs [19]. The criteria for severe sepsis are the presence of systemic inflammatory response syndrome due to infection and the presence of organ dysfunction. a) Patients must have at least 3 of the following 4 criteria: 1. core temperature ³38oC or £36oC 2. heart rate ³90 beats/min unless known medical condition associated with increased heart rate or on medication that will prevent increased heart rate. 3. respiratory rate ³20 breaths/min or PaCO2 (partial pressure of carbon dioxide in arterial blood) 32 mmHg or receiving mechanical ventilation for acute respiratory failure. 4. white cell count ³12,000/mL or £4,000/mL or a differential count showing >10% immature neutrophils. PLUS One of the following six criteria must be present to confirm that the episode is due to infection: 1. polymorphonuclear cells in normally sterile site 2. culture of pathogenic organism from normally sterile site 3. chest x-ray changes consistent with pneumonia 4. focus of infection identified visually 5. underlying disease or condition known to be associated with infection (eg ascending cholangitis) 6. other (reason to be stated) PLUS Organ dysfunction entry criteria as described previously [19]. 4. Patients who consent or if the patient is incompetent, the next-of-kin who consent, to inclusion in the study.
排除标准
- •Patients will be excluded if, in the opinion or knowledge of the responsible clinician, any of the following criteria apply: 1. Patients aged less than 18 years. 2. Patient is receiving continued full anticoagulation treatment for another reason with either heparin or coumarin agents. 3. Patients with a contra-indication to low-dose heparin including intracranial haemorrhage, active bleeding, or Heparin induced Thrombcytopenia (HIT) in the past 3 months. 4. Patients with a prior adverse reaction to heparin. 5. Patients or next-of-kin do not consent to inclusion in the study.
研究者
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