ISRCTN66727957
已完成
不适用
Vasopressin and Corticosteroids in septic Shock: an open-label randomised controlled trial
Imperial College London (UK)0 个研究点目标入组 60 人2010年9月10日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Topic: Generic Health Relevance and Cross Cutting Themes
- 发起方
- Imperial College London (UK)
- 入组人数
- 60
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •The target population is adult patients who require vasopressors for the management of sepsis despite fluid resuscitation. These patients will require management on the intensive care unit.
- •Inclusion criteria will use the internationally\-established consensus definitions of sepsis. In brief:
- •1\. Fulfil 2/4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
- •1\.1\. Fever (greater than 38°C) or hypothermia (less than 36°C)
- •1\.2\. Tachycardia (heart rate greater than 90 beats per minute)
- •1\.3\. Tachypnea (respiratory rate greater than 20 breaths per minute or partial pressure of carbon dioxide in the blood \[PaCO2] less than 4\.3 kPa) or need for mechanical ventilation
- •1\.4\. Abnormal leukocyte count (greater than 12,000 cells/mm3, less than 4000 cells/mm3, or greater than 10% immature \[band] forms)
- •2\. Hypotension despite adequate intravenous fluid resuscitation (minimum of 1 litre in the previous four hours)
- •3\. Aged greater than or equal to 16 years, either sex
排除标准
- •1\. Patient has received a continuous infusion of vasopressors previously during this hospital admission (other than vasopressors used as emergency treatment to stabilise the patient during this episode). Vasopressors include noradrenaline, adrenaline, vasopressin, dopamine, metaraminol, phenylephrine.
- •2\. Regular systemic corticosteroid therapy within the previous three months (this does not include inhaled steroid therapy)
- •3\. End\-stage renal failure
- •4\. Known adrenal dysfunction/insufficiency
- •5\. Physician and team are not committed to full active care
- •6\. Patient who is terminally ill (death anticipated within 24 hours)
- •7\. Patient is known to be pregnant
- •8\. Patient has known acute mesenteric ischaemia
- •9\. Patient is being actively treated for an acute coronary syndrome
- •10\. Patient is known to have Raynaud's phenomenon, systemic sclerosis or other vasospastic diseases
结局指标
主要结局
未指定
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Vasopressin and Corticosteroids in Septic Shock - Vasopressin and Corticosteroids in Septic Shock. Version 1.0Septic shock - low blood pressure due to infectionEUCTR2009-017636-41-GBImperial College
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