Up Regulation of Alpha-1 Receptors Upon Septic Shock ?
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in pressor response to exogenous noradrenaline
研究概览
简要总结
The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •patients presenting to the CCU with septic shock : SBP<90 mm Hg refractory to volume load (>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for >1 h (0.1 mcg.kg-1.h-1 i.e. >0.5 mg.h-1/70 kg) to maintain mean BP>65 mm Hg.
- •criteria for sepsis :temperature>38.5 or <36°C ; WBC>12 000 or <4000/ml ; tachypnea (>20 cycles par min) or mechanical ventilation ; tachycardia : >90 bpmin
- •written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"
排除标准
- •age<18 ans
- •pregnancy
- •mental illness making informed consent impossible
- •Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
- •individual without social security coverage or participating in another biomedical research
- •Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
- •HR<70 bp/min
- •pre-exitus
研究组 & 干预措施
placebo
saline administration over 24 h following full optimization of patient according to current guidelines
干预措施: Placebo (Drug)
clonidine
clonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines
干预措施: Clonidine (Drug)
结局指标
主要结局
change in pressor response to exogenous noradrenaline
时间窗: 0 and 24 h
bolus of exogenous noradrenaline (1 mcg and up) are administered to the patient to evoke an increase in delta systolic blood pressure by 25-30 mm Hg. Administration of increasing dose of noradrenaline is stopped as soon as delta systolic blood pressure has reached 25-30 mm Hg.
次要结局
- change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.(0 and 24 h)
研究者
Eric Dardare
MD attending physician
Direction Centrale du Service de Santé des Armées