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 人开始时间: 2010年9月10日最近更新: 2015年1月13日

适应症

试验速览

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•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

•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
•11. Patient is enrolled in another interventional trial that might interact with the study drugs
•12. Patients has a history of anaphylaxis to any study drug

发起方

Imperial College London (UK)