NCT00684736已完成不适用
Tryptophan, Serotonin and Kynurenine in Septic Shock
Versailles Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors
研究概览
简要总结
Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above or equal to 18 years
- •Strong presumption clinical sepsis
- •Need for mechanical ventilation
- •Body temperature above 38°C or below 36°C
- •Heart rate above 90 bpm
- •Systolic blood pressure of <90mm Hg despite adequate fluid replacement or a need for vasopressors less than 3 hours
- •Presence of at least one of the following criteria:
- •Ratio of arterial oxygen tension over inspired fraction of oxygen of less than 300 mm Hg
- •Urinary output below 0.5 mL per kg of bodyweight per h or below 30 mL/h (for at least 1 h)
- •Arterial lactate concentration above 2 mmol/L
- •Consent signed
排除标准
- •Age below 18 years
- •Pregnancy
- •Underlying disease with a poor prognosis, a life expectancy of less than 24 hours
- •Depression or melancholy
- •Neuropsychiatric diseases: Seizure, manic psychosis, Migraine, or Drug addiction
- •Neuroendocrine tumors
- •Obstructive cardiomyopathy or acute myocardial ischaemia
- •Pulmonary embolism
- •Advanced stage cancer, malignant haemopathy, or AIDS with a decision to withhold or withdraw aggressive therapies
- •Inclusion in another clinical trial
- •Patient who receive before inclusion one of the following treatment known to modify serotonin level: almotriptan, amitriptyline, amoxapine, citalopram, clomipramine, clozapine, desipramine, dihydroergotamine, dolasetron, dosulepin, doxepin, eletriptan, ergotamine, flunarizine, fluoxetine, fluvoxamine, granisetron, imipramine, indoramin, interferon Alfa, interferon alfacon-1, interferon beta, iproniazid, maprotiline, methysergide, mianserin, Milnacipran, mirtazapine, moclobemide, naratriptan, olanzapine, ondansetron, oxetorone, paroxetine, pizotifen, risperidone, sertraline, sumatriptan, tianeptine, trimipramine, tropisetron, venlafaxine,viloxazine, zolmitriptan.
- •No consent
结局指标
主要结局
Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors
时间窗: Day-1, Day-2, Day-3, Day-7 and Day-14
次要结局
- Mortality(28-day)
研究者
研究点 (1)
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